CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION

his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center.
Primary objective
Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use;
Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use.
Secondary objective
Evaluation of flares quantity and severity during 84 and 168 days of use;
Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days;
Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days;
Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days;
Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days;
Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days;
The folliculitis incidence after 14, 28, 84 and 168 days;
Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days;
Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days.
Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days.
Illustrative clinical pictures of one or two affected areas.

Start Date20 Dec 2021

Sponsor / Collaborator

Cosmetique Active International

NCT04179461 / CompletedPhase 2IIT

Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

Start Date16 Mar 2018

Sponsor / Collaborator

Children's Hospital & Medical Center

NCT00806221 / CompletedPhase 2IIT

An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis

The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

Start Date01 Nov 2006

Sponsor / Collaborator

Oregon Health & Science University

[+1]

100 Clinical Results associated with Prednicarbate

100 Translational Medicine associated with Prednicarbate

100 Patents (Medical) associated with Prednicarbate

177

Literatures (Medical) associated with Prednicarbate

01 Mar 2024·EClinicalMedicine

Safety and efficacy of whole-body chlorhexidine gluconate cleansing with or without emollient in hospitalised neonates (NeoCHG): a multicentre, randomised, open-label, factorial pilot trial

Article

Author: Bielicki, Julia ; Islam, Mohammad Shahidul ; Azmery, Kazi Shammin ; LeBeau, Kristen ; O'Brien, Seamus ; Schiavone, Francesca ; Dramowski, Angela ; Bekker, Adrie ; Russell, Neal ; Walker, Ann Sarah ; Ellis, Sally ; Clements, Michelle N ; Skoutari, Peter ; Hoque, Mahbubul ; Fataar, Aaqilah ; Saha, Samir K ; Sharland, Michael ; Whitelaw, Andrew

Background:

Healthcare-associated infections account for substantial neonatal in-hospital mortality. Chlorhexidine gluconate (CHG) whole body skin application could reduce sepsis by lowering bacterial colonisation density, although safety and optimal application regimen is unclear. Emollients, including sunflower oil, may independently improve skin condition, thereby reducing sepsis. We aimed to inform which concentration and frequency of CHG, with or without emollient, would best balance safety and the surrogate marker of efficacy of reduction in bacterial colonisation, to be taken forward in a future pragmatic trial evaluating clinical outcomes of sepsis and mortality.

Methods:

In this multicentre, randomised, open-label, factorial pilot trial, neonates in two hospital sites (South Africa, Bangladesh) aged 1-6 days with gestational age ≥ 28 weeks and birthweight 1000-1999 g were randomly assigned in a factorial design stratified by site to three different concentrations of CHG (0.5%, 1%, and 2%), with or without emollient (sunflower oil) applied on working days vs alternate working days. A control arm received neither product. Caregivers were unblinded although laboratory staff were blinded to randomisation Co-primary outcomes were safety (change in neonatal skin condition score incorporating dryness, erythema, and skin breakdown) and efficacy in reducing bacterial colonisation density (change in total skin bacterial log₁₀ CFU from randomisation to day-3 and day-8). The trial is registered at the ISRCTN registry, ISRCTN 69836999.

Findings:

Between Apr 12 2021 and Jan 18 2022, 208 infants were randomised and 198 were included in the final analysis. Skin condition scores were low with mean 0.1 (sd = 0.3; N = 208) at baseline, 0.1 (sd = 0.3; N = 199) at day 3 and 0.1 (sd = 0.3; N = 189) at day 8, with no evidence of differences between concentration (1% CHG vs 0.5% estimate = -0.3, 95% CI = (-1.2, 0.6), p = 0.55. 2% CHG vs 0.5% CHG estimate = 0.5 (-0.4, 1.4), p = 0.30), increasing frequency (estimate = -0.4; 95% CI = (-1.1, 0.4), p = 0.33), emollient (estimate = -0.5, (-1.2, 0.3), p = 0.23) or with control (estimate = -0.9, (-2.3, 0.4), p = 0.18). Mean log₁₀ CFU was 4.9 (sd = 3.0; N = 208) at baseline, 6.3 (sd = 3.1; N = 198) at day 3 and 8.4 (sd = 2.6; N = 183) with no evidence of differences between concentration (1% CHG vs 0.5% estimate = -0.4; 95% CI = (-1.1, 0.23); p = 0.23. 2% CHG vs 0.5% CHG estimate = 0.0 (-0.6, 0.6), p = 0.96), with increasing frequency (estimate = -0.4; 95% CI = (-0.9, 0.2); p = 0.17), with emollient (estimate = 0.4, 95% CI = (-0.2, 0.9); p = 0.18) or with control (estimate = -0.2, 95% CI = (-1.3, 0.9); p = 0.73). By day-8, overall 158/183 (86%) of neonates were colonised with Enterobacterales, and 72/183 (39%) and 69/183 (9%) with Klebsiella spp resistant to third-generation cephalosporin and carbapenems, respectively. There were no CHG-related SAEs, emollient-related SAEs, grade 3 or 4 skin scores or grade 3 or 4 hypothermias.

Interpretation:

In this pilot trial of CHG with or without sunflower oil, no safety issues were identified, and further trials examining clinical outcomes are warranted. The relatively late start application of emollient, at a mean of 3.8 days of life, may have reduced the impact of the intervention although no subgroup effects were detected. There was no clear evidence in favour of a specific concentration of chlorhexidine, and there was rapid colonisation with Enterobacterales with frequent antimicrobial resistance, regardless of skin application regimen.

Funding:

The MRC Joint Applied Global Health award, the Global Antibiotic Research and Development Partnership (GARDP), MRC Clinical Trials Unit core funding (UKRI) and St. George's, University of London.

01 Jan 2024·Mycoses

Comparing emollient use with topical luliconazole (azole) in the maintenance of remission of chronic and recurrent dermatophytosis. An open‐label, randomized prospective active‐controlled non‐inferiority study

Article

Author: Pathania, Yashdeep Singh ; Kumar, Ashok ; Cds, Katoch

Abstract:

Background:

Literature on emollient use in the management of chronic and recurrent dermatophytosis is limited.

Objective:

To assess the efficacy of emollient in the remission maintenance of chronic and recurrent dermatophytosis.

Methods:

In this randomized open‐label study with the intention to treat, 80 patients with chronic recurrent dermatophytosis were randomized into two groups, where both groups were treated adequately for 6 weeks, followed by continuation of topical azole in group A and topical emollient in group B for 6 weeks. Clinical remission was determined by disappearance signs and symptoms of tinea lesions with or without hyperpigmentation. Physician and patient global assessment scores were evaluated every 2 weeks for 6 weeks to assess remission maintenance.

Results:

A total of 80 patients of chronic and recurrent dermatophytosis were assessed for remission maintenance. The recurrence of disease occurred in 20 patients overall, wherein 7 patients (17.5%) in group A and 13 patients (32.5%) in group B at the end of the study (18 weeks); however, the difference between the two groups was not statistically significant (p = .121). The mean physician global assessment scores of group A and group B at 12 weeks were 4.45 ± 0.74 and 4.15 ± 0.92, 4.43 ± 0.90 and 4.10 ± 0.98 at 14 weeks, 4.0 ± 1.32 and 3.98 ± 1.23 at 16 weeks, 3.85 ± 1.44 and 3.90 ± 1.35 at 18 weeks, respectively. The mean patient global assessment scores of group A and group B were 4.65 ± 0.62 and 4.25 ± 0.87 at 12 weeks, 4.40 ± 0.87 and 4.17 ± 0.98 at 14 weeks, 4.18 ± 1.15 and 4.12 ± 1.30 at 16 weeks and 3.97 ± 1.33 and 3.90 ± 1.51 at 18 weeks.

Conclusion:

The present study concludes that the efficacy of emollient was not inferior to topical luliconazole for maintaining remission in chronic and recurrent dermatophytosis.

01 Oct 2023·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

Emollients for preventing atopic eczema: Cost-effectiveness analysis of the BEEP trial.

Article

Author: Sach, Tracey H ; Haines, Rachel H ; Cork, Mike J ; Lartey, Stella T ; Thomas, Kim S ; Jay, Nicola ; Mitchell, Eleanor ; Bradshaw, Lucy E ; Ridd, Matthew J ; Perkin, Michael R ; Montgomery, Alan A ; Wyatt, Laura ; Boyle, Robert J ; Lawton, Sandra ; Kelleher, Maeve M ; Chalmers, Joanne R ; Davies-Jones, Susan ; Davies, Charlotte ; Williams, Hywel C ; Tarr, Stella ; Brown, Sara J ; Flohr, Carsten ; Swinden, Richard

BACKGROUND:

Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy.

OBJECTIVE:

To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis.

METHODS:

A within-trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost-effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost-effectiveness analysis. Secondary analysis, undertaken as a cost-utility analysis, reports incremental cost per Quality-Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU-9D at 2 years.

RESULTS:

At 2 years, the adjusted incremental cost was £87.45 (95% CI -54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI -0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI -0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, -£106.89 (95% CI -354.66, 140.88) and the proportion without eczema was -0.0329 (95% CI -0.0659, 0.0002). The 5-year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group.

CONCLUSIONS:

In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high-risk children does not appear cost-effective.

News (Medical) associated with Prednicarbate

20 Apr 2023

·www.biospace.com

Resilia Pharmaceuticals Announces Relaunch of Solace® Eczema Cream On Amazon®

Formerly Available only by Prescription, Solace® is First of Several Over-the-Counter Products to be Marketed Under Resilia's Santefirm Consumer Healthcare Label ATLANTA, April 19, 2023 /PRNewswire/ -- Resilia Pharmaceuticals, Inc. announced today that it has re-launched Solace® Eczema Cream on Amazon® and restored the supply of this product that had formerly only been available by prescription. Solace is marketed under Resilia's Santefirm Consumer Healthcare, Inc.™ label. Resilia Pharmaceuticals Announces Relaunch of Solace® Eczema Cream on Amazon® Solace® Cream is formulated to help control eczema flares and keep future eczema flares dormant longer by utilizing essential skin building blocks like cholesterol, fatty acids, and ceramides to help reduce the likelihood of environmental triggers causing eczema symptoms; as well as employing palmitamide MEA (PEA), a natural endogenous fatty acid to help relieve itchy, dry skin often associated with eczema. Solace® is available on Amazon® at "We are delighted to be able to bring Solace® back to the market," said Harsha Murthy, Executive Chairman of the Board of Directors at Resilia Pharmaceuticals. "We are also pleased that Solace® will be the first of many non-prescription, over-the-counter products that Santefirm will be launching in the coming months and years," Mr. Murthy said. "We are committed to meeting patients where they are when they need relief from dermatological conditions, Solace® gives patients a high-quality treatment option at a highly reasonable price and takes advantage of Amazon's world-class fulfillment/delivery channel." Andrew Shales, Chief Executive Officer of Resilia, noted, "Solace® is an ideal complement to our prescription line of dermatology products sold under our Resilia label. We know that patients experience skin conditions in a range of severity, from acute and severe outbreaks to chronic symptoms. Resilia and Santefirm have developed a product portfolio that can help patients at each stage, and we anticipate our additional product offerings will address even more of our patients' needs. Patients in consultation with their physicians/prescribers/health care professionals can now get the type of treatment best suited to their needs." Mike Leone, Chief Operating Officer of Resilia, said "Since acquiring the rights to Solace® in October 2021, the Resilia and Santefirm teams have worked closely with our manufacturing partners to bring this product back to patients suffering with eczema." Leone continued, "We have restored the supply chain to ensure the availability of the product. Moreover, we anticipate that we will undertake new promotional efforts to alert patients to the scientifically supported benefits of Solace® and the ease with which they can get Solace® on Amazon®." About Solace® Cream ( ) Solace® Cream: repairs and restores the skin barrier; keeps eczema in remission up to 48% longer1 reduces average weekly steroid applications by 62%2 improves sleep quality3 About Eczema Eczema symptoms are different for everyone, though in most cases, eczema causes itching and can make skin appear dry, red, rough, or swollen. This itching can be mild or severe, resulting in inflamed and even damaged skin. While the specific cause of eczema remains unknown, healthcare professionals believe the disease often occurs from a combination of factors. Professionals believe that environmental irritants, like detergents, allergens, and bacteria, as well as shifts in temperature, types of foods, stress, or hormones, can cause an eczema flare-up. About Resilia Pharmaceuticals™ and Santefirm Consumer Healthcare, Inc™. Resilia Pharmaceuticals, Inc™. is a portfolio company of Peak Pharma Commercial Partners, a New York City-based investment fund dedicated to the acquisition and growth of branded, generic and over-the-counter pharmaceutical products (www. peakpharmapartners.com). Headquartered in Atlanta, Georgia, Resilia Pharmaceuticals' prescription product line consists of Recedo® topical gel, the #1 prescribed Rx scar treatment over the past 5 years3; Ecoza® (econazole nitrate) topical foam, 1%; the Neosalus® line, including cream, foam, and lotion formulations for eczema/atopic dermatitis; and Neocera®, a version of Neosalus formulated with ceramides. Santefirm Consumer Healthcare, Inc™., also headquartered in Atlanta, Georgia, is the Resilia affiliate that sells non-prescription, over-the-counter products. All of Resilia and Santefirm's respective products are marketed and manufactured in the US. To learn more about Resilia Pharmaceuticals, Santefirm and their products, please go to and Citations: Kircik L. A Nonsteroidal Lamellar Matrix Cream Containing Palmyitoyethanolamide for the Treatment of Atopic Dermatitis. J Drugs Dermatol. 2010; 4: 334. Eberlein B, Eicke C, Reinhardt HW, Ring J. Adjuvant Treatment of Atopic Eczema: Assessment of an Emollient Containing N-palmitoylethanolamine (ATOPA study). J Eur Acad Dermatol Venereol. 2008; 22(1): 73-82. Symphony Health. Defined Scar Treatment Market TRxs, Jan 2017-Aug 2021 Contact: info@resiliapharmaceuticals.com Phone: 888-998-0770

Drug Approval

01 Jul 2022

·www.prnewswire.com

Insights on the Hand Sanitizer Global Market to 2027 - by Product Form, Product Type, Distribution Channel, End-use and Region

DUBLIN, July 1, 2022 /PRNewswire/ -- The "Hand Sanitizer Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global hand sanitizer market reached a value of US$ 6.0 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 2.9 Billion by 2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor. A hand sanitizer, or a hand rub, is an antiseptic solution applied on the hands to remove disease-causing pathogens from the skin. It is commonly available in foam, gel and liquid-based variants and consists of alcohol, water, emollients, polyacrylates, artificial and natural colors and fragrances. The alcohol used in hand sanitizers includes ethanol and isopropanol, which instantly denatures proteins and destroys the lipid-based coatings of certain bacteria and viruses. The water acts as a carrier for the ingredients and bonds with the hydrogel. The emollients and other ingredients are added in small quantities to protect the skin from dryness caused by the alcohol, neutralize the acidic effects of polyacrylate and enhance the smell and appearance of the product. Currently, alcohol-free variants are also available, which are manufactured using glycerin, thickening agents and disinfectants, such as benzalkonium chloride (BAC) and other antimicrobial agents. Hand sanitizers also contain humectants that attract and lock moisture in the hands and do not remove natural oils from the skin despite repetitive use. In comparison to the traditionally used soap, these sanitizers are more effective and gentler on the skin. As coronavirus disease (COVID-19) continues to spread across the globe, there has been a significant increase in the demand for hand sanitizers in schools, hospitals, residential and commercial complexes and other public spaces. However, with the ease of lockdown regulations and an overall decline in the number of cases globally, there is a significant drop in the demand and sales of hand sanitizers. Global Hand Sanitizer Market Trends: The Spread of Coronavirus Disease (COVID-19) Across the Globe With the sudden outbreak of the COVID-19 pandemic, the World Health Organization (WHO) has recommended the use of hand sanitizers for self-preservation and minimizing the spread of the coronavirus. The increasing number of deaths caused by the virus has further triggered an alarming response from consumers, thereby increasing the emphasis of consumers on hand hygiene as a preventive measure from contracting the infection. Hand sanitizers contain a high percentage of alcohol, which removes the envelope coating of the virus, thereby making it non-infectious and providing continuous protection to the user. Rising Health Consciousness Among the Masses The increasing demand for hand sanitizers is further supported by the rising prevalence of various gastrointestinal, respiratory and skin infections among the masses. Alcohol-based hand sanitizers can minimize the transmission of harmful bacteria and viruses present on the skin or palm of the hands, thereby reducing the instances of stomach infections, diarrhea, nausea and vomiting. In comparison to the traditionally used hand washes and soaps, hand sanitizers contain ingredients that can also aid in minimizing dryness and irritation on the skin. Product manufacturers are developing sanitizers with natural and organic ingredients that do not cause allergies and are non-toxic in nature. The Introduction of Novel Variants and Dispensers The market is also driven by the launch of innovative hand sanitizers infused with floral and fruit fragrances. Product manufacturers are developing easy-to-use and portable foam and gel-based sanitizers in sachets and mini-bottles. The gel-based sanitizers have a thin and watery consistency that spread and penetrate the skin quickly to neutralize the pathogens. Similarly, foam-based hand sanitizers are also highly convenient to use and do not need to be rubbed off. Manufacturers are launching products in innovative flavors, such as strawberry, green apple, litchi and orange, in novel hands-free automatic sensor-based and foot-operated dispensers. Product Availability Through Online Retail Channels The market is also driven by the proliferation of online retail channels and social media platforms. Consumers are increasingly becoming aware of the availability of premium personal care and hygiene products and are widely adopting healthy lifestyles. Product vendors are using innovative marketing strategies to promote sanitation products through influential celebrities and sports personalities to reach and attract a broader consumer base. They are also developing attractive packaging to grab the consumer's attention and provide them with an authentic and luxurious experience through their high-quality products. Through online retail platforms, consumers are now able to place orders from the convenience of their homes and the product manufacturers and vendors are able to reach the audiences present in remote locations. Competitive Landscape: The report has also analyzed the competitive landscape of the market with some of the top hand sanitizer manufacturers being Reckitt Benckiser Group PLC, The Himalaya Drug Company, The Procter & Gamble Company, Henkel AG & Company, Unilever PLC, Vi-Jon Laboratories Inc., Gojo Industries, Inc., Sanofi S.A., Kutol Products Company, Inc., and The 3M Company. Key Questions Answered in This Report 1. What is the size of the global hand sanitizer market? 2. What has been the impact of COVID-19 on the global hand sanitizer market? 3. What are the key factors driving the global hand sanitizer market? 4. What is the breakup of the global hand sanitizer market based on the product form? 5. What is the breakup of the global hand sanitizer market based on the product type? 6. What is the breakup of the global hand sanitizer market based on the end use? 7. What are the key regions in the global hand sanitizer market? 8. Who are the key players/companies in the global hand sanitizer market? Key Topics Covered: 1 Preface 2 Scope and Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Hand Sanitizer Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Product Form 6.1 Gel 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Liquid 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Spray 6.3.1 Market Trends 6.3.2 Market Forecast 6.4 Foam 6.4.1 Market Trends 6.4.2 Market Forecast 6.5 Others 6.5.1 Market Trends 6.5.2 Market Forecast 7 Market Breakup by Product Type 7.1 Alcohol-Based 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Non-Alcohol Based 7.2.1 Market Trends 7.2.2 Market Forecast 8 Market Breakup by Distribution Channel 8.1 B2B 8.1.1 Market Trends 8.1.2 Market Breakup by End Use 8.1.2.1 Hospitals 8.1.2.1.1 Market Trends 8.1.2.1.2 Market Forecast 8.1.2.2 Other Institutions 8.1.2.2.1 Market Trends 8.1.2.2.2 Market Forecast 8.1.3 Market Forecast 8.2 Retail 8.2.1 Market Trends 8.2.2 Market Breakup by Channel 8.2.2.1 Hypermarkets/Supermarkets 8.2.2.1.1 Market Trends 8.2.2.1.2 Market Forecast 8.2.2.2 Pharmacy Stores 8.2.2.2.1 Market Trends 8.2.2.2.2 Market Forecast 8.2.2.3 Online Stores 8.2.2.3.1 Market Trends 8.2.2.3.2 Market Forecast 8.2.2.4 Departmental Stores 8.2.2.4.1 Market Trends 8.2.2.4.2 Market Forecast 8.2.2.5 Others 8.2.2.5.1 Market Trends 8.2.2.5.2 Market Forecast 8.2.3 Market Forecast 9 Market Breakup by End Use 9.1 Hospitals 9.1.1 Market Trends 9.1.2 Market Forecast 9.2 Households 9.2.1 Market Trends 9.2.2 Market Forecast 9.3 Manufacturing 9.3.1 Market Trends 9.3.2 Market Forecast 9.4 Hospitality 9.4.1 Market Trends 9.4.2 Market Forecast 9.5 Restaurants 9.5.1 Market Trends 9.5.2 Market Forecast 9.6 Government/Utilities (Except Educational Institutes) 9.6.1 Market Trends 9.6.2 Market Forecast 9.7 Schools and Educational Institutes 9.7.1 Market Trends 9.7.2 Market Forecast 9.8 Enterprise and Commercial Facilities 9.8.1 Market Trends 9.8.2 Market Forecast 9.9 Recreational and Entertainment Centers 9.9.1 Market Trends 9.9.2 Market Forecast 9.10 Agriculture 9.10.1 Market Trends 9.10.2 Market Forecast 9.11 Others 9.11.1 Market Trends 9.11.2 Market Forecast 10 Market Breakup by Region 11 SWOT Analysis 12 Value Chain Analysis 13 Porters Five Forces Analysis 14 Price Analysis 14.1 Key Price Indicators 14.2 Price Structure 14.3 Margin Analysis 15 Competitive Landscape 15.1 Market Structure 15.2 Key Players 15.3 Profiles of Key Players 15.3.1 Reckitt Benckiser Group PLC 15.3.2 The Himalaya Drug Company 15.3.3 The Procter & Gamble Company 15.3.4 Henkel AG & Company 15.3.5 Unilever PLC 15.3.6 Vi-Jon Laboratories Inc. 15.3.7 Gojo Industries, Inc. 15.3.8 Sanofi S.A. 15.3.9 Kutol Products Company, Inc. 15.3.10 The 3M Company For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

20 Apr 2021

·www.biospace.com

Evelo Biosciences Presents Further Positive Data from Phase 1b Clinical Trial of EDP1815 in Atopic Dermatitis

–Evelo presents late-breaking abstract at the International Society of Atopic Dermatitis Annual Meeting– –Meaningful improvements over placebo on clinical scores, including new data released on key IGA endpoints– –Initiation of Phase 2 trial of EDP1815 in atopic dermatitis expected in 3Q 2021– CAMBRIDGE, Mass., April 20, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today presented full clinical data from the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild and moderate atopic dermatitis in a poster presentation at the International Society of Atopic Dermatitis (ISAD) Hybrid Meeting 2021. The Company previously reported positive data for all 24 patients in the cohort, which is re-iterated in the presentation, together with new data on the Investigator Global Assessment (IGA) score. The primary endpoint of the Phase 1b trial was safety and tolerability. As previously disclosed, EDP1815 was well tolerated, with no treatment-related adverse events of moderate or severe intensity and no serious adverse events. The full results reinforce the data released on January 20, 2021, demonstrating that treatment with EDP1815 resulted in clinically meaningful improvements in both patient- and physician-reported outcomes. At the day 70 follow-up visit, 31% more EDP1815-treated patients achieved an IGA score of 0 or 1 greater than placebo. At this same time point, 19% more EDP1815-treated patients reached an IGA score of 0 or 1 with a two-point improvement from baseline greater than placebo. This, in addition to the treatment differences seen within the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and IGA times Body Surface Area (IGA*BSA) clinical endpoints as shown in the image below, suggests the potential of EDP1815 to be an effective, safe, well-tolerated, oral treatment for patients with mild and moderate atopic dermatitis. Photos accompanying this announcement are available at: “We are pleased to present this complete dataset from our Phase 1b cohort at the ISAD conference, as it demonstrates the strong potential of EDP1815 as a therapy for patients with atopic dermatitis – many of whom are underserved by a lack of effective, convenient, safe treatment options,” said Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo. “We are further encouraged by the IGA data, which showed that EDP1815 has the potential to provide clinical benefit to patients. We look forward to initiating our Phase 2 atopic dermatitis trial in the third quarter of this year in patients with mild, moderate and severe atopic dermatitis.” About the EDP1815 Phase 1b Clinical Trial EDP1815-101 is a double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety and tolerability of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis. The atopic dermatitis cohort enrolled 24 patients with mild and moderate atopic dermatitis, randomized 2:1 to receive oral administration of the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days, with follow-up at day 70. Patients were not allowed to use active topical treatments and were not required to use emollients. The primary endpoint was safety and tolerability. Secondary endpoints included a range of established markers of atopic dermatitis. About EDP1815 EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from five independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation. In the psoriasis cohorts of the Phase 1b clinical trial, EPD1815 was also observed to limit the systemic production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which are well-established mediators of potentially harmful effects in patients with inflammatory diseases. Preclinical and clinical data to date showed that EDP1815 achieved this anti-inflammatory activity without inducing immunosuppression. EDP1815 has been observed to be well-tolerated in clinical studies to-date. About Atopic Dermatitis Atopic dermatitis, also known as eczema, is a common chronic inflammatory skin disease that affects both children and adults, with a prevalence of up to 3-6% in adults worldwide. It typically presents as a red, intensely itchy rash that may cause lifelong symptoms. Due to the chronic nature and frequency of relapses, atopic dermatitis is associated with a substantial physical and psychosocial burden on patients and their families. It can also occur alongside other atopic diseases including food allergy, asthma, and allergic rhinitis, as these conditions are all associated with an imbalance towards a Th2 inflammatory response – an immune pathway on which EDP1815 has been shown to have potent pre-clinical, and now also clinical, activity. Patients with atopic dermatitis are often treated with topical medications, which are inconvenient and burdensome in application, leading to poor adherence and reduced efficacy in a real-world setting. Beyond topicals, patients have limited treatment options, especially patients with mild and moderate disease, who represent 80-90% of atopic dermatitis patients worldwide. This group of patients typically do not have access to high-cost, injectable antibody therapies or may be uncomfortable with the toxicity concerns and monitoring requirements of systemic immunosuppressants. There is a large need across the spectrum of disease severity, especially for the midline, pre-biologic patients, for a safe and well-tolerated oral medicine that resolves the systemic inflammation that drives atopic dermatitis. About Evelo Biosciences Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that act on SINTAX™, the small intestinal axis, to have systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties. Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas. For more information, please visit and engage with Evelo on LinkedIn. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the development of EDP1815, the timing of and plans for clinical trials, and the promise and potential impact of EDP1815. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contact Jessica Cotrone, 978-760-5622 jcotrone@evelobio.com Treatment Difference between EDP1815 and Placebo for EASI, IGA*BSA, and SCORAD throughout the study treatment period Data presented at the International Society of Atopic Dermatitis (ISAD) Hybrid Meeting 2021 Atopic Dermatitis Phase 1b Positive Trial Results for EDP1815, An Oral Single-Strain Commensal Microbe Data presented at the International Society of Atopic Dermatitis (ISAD) Hybrid Meeting 2021

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Indication	Country/Location	Organization	Date
Skin Diseases	US	Bausch Health Cos., Inc.	23 Sep 1991

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04179461 (CTgov)	Phase 2	Childhood asthma	21	antihistamine+emollient cream+Azithromycin+Fluticasone Propionate+Cholecalciferol	ygkvosslej(hhrkpbstae) = rrzwcfnzsn tghsnpgumr (fjfklpvvbs, vvvhdhpknv - lgokqhuqyz) View more	-	20 Aug 2021
NCT00806221 (CTgov)	Phase 2	Dermatitis, Atopic	22	emollient (Cetaphil cream)	umfldbgthi(xytghtuejg) = maksyrbjwh rtbxxesgtn (dplevkylxs, rfeplqqhgd - awwqafdhot) View more	-	11 Jul 2017

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