A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Start Date22 Apr 2024

Sponsor / Collaborator

Famy Life Sciences Pvt Ltd.

CTRI/2024/03/063709

/ RecruitingNot Applicable

A Randomized, Double Blind, Placebo Controlled, Three arm, Parallel, Multicentre, Study to Evaluate the Bioequivalence using Clinical Endpoint of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India to Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Treatment of Mild to Moderate Atopic Dermatitis. - Nil

Start Date15 Mar 2024

Sponsor / Collaborator

Encube Ethicals Pvt Ltd.

NCT06241118

/ RecruitingPhase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.
Study details include:
At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).
The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.
The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period.
The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

Start Date29 Feb 2024

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Pimecrolimus

100 Translational Medicine associated with Pimecrolimus

100 Patents (Medical) associated with Pimecrolimus

1,154

Literatures (Medical) associated with Pimecrolimus

01 Apr 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Low‐dose isotretinoin for the management of rosacea: A systematic review and meta‐analysis

Review

Author: Tan, Marcus G. ; Kirshen, Carly ; Tolkachjov, Stanislav N. ; King, Aliyah

Abstract:

Background:

Rosacea is a chronic, relapsing inflammatory dermatosis predominantly affecting the central face and can result in significant psychosocial impacts. Isotretinoin has been studied for rosacea due to its anti‐inflammatory and sebum reduction properties, but its use remains limited likely due to its off‐label use and potential adverse events.

Objective:

This systematic review and meta‐analysis investigated the efficacy and safety of low‐dose isotretinoin (LDI; ≤0.5 mg/kg/day) for the four main types of rosacea: erythematotelangiectatic, papulopustular, phymatous and ocular rosacea.

Methods:

Randomized and non‐randomized studies evaluating LDI for rosacea were included. Incomplete studies, non‐English studies and case reports were excluded. Study quality was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation scale.

Results:

Of 435 studies, and 16 studies involving 1445 patients were included. LDI decreased lesion count (p = 0.03) and erythema (p = 0.01) with large effect [standardized mean difference (SMD) > 0.8]. Compared to topical retinoids and topical antimicrobials, isotretinoin had larger reductions in lesion count (p = 0.03) with moderate effect (SMD > 0.5). Mean lesion count and erythema remained reduced by 70% and 47%, respectively, at 16 weeks after LDI cessation. Relapse rate was 35% at 5.5 months post‐isotretinoin, and three patients (0.4%) experienced worsening of rosacea. Three patients (0.4%) experienced serious adverse events.

Conclusions:

Study design heterogeneity limited more comprehensive comparisons. Overall, low‐dose isotretinoin may serve as an effective treatment for rosacea with good tolerability and safety.

01 Apr 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Management of human epidermal growth factor receptor inhibitors‐related acneiform rash: A position paper based on the first Europe/USA Delphi consensus process

Article

Author: Freites‐Martinez, A. ; Mateeva, V. ; Deverapalli, S. ; Ortiz‐Brugues, A. ; Kluger, N. ; Romano, P. ; Hirner, J. ; Kwong, B. ; Beylot‐Barry, M. ; Nikolaou, V. ; Babakoohi, S. ; Fattore, D. ; Hassel, J. ; Lacouture, M. ; Kheterpal, M. ; Reyes‐Habito, C. M. ; Apalla, Z. ; Smith, J. ; Galimont, A. ; Fida, M. ; Patel, A. B. ; Starace, M. ; Grafanaki, K. ; Carrera, C. ; Sauder, M. ; Leboeuf, N. ; Dodiuk‐Gad, R. ; Riganti, J. ; Sollena, P. ; Iriarte, C. ; Kraehenbuehl, L. ; Whitley, M. ; Larocca, C. ; Tattersall, I. ; Sibaud, V.

Abstract:

Background:

There is a need for unified guidance in the management of acneiform rash induced by epidermal growth factor receptor inhibitors (EGFRi) among dermatologists.

Objective:

To establish unified international guidelines for the management of acneiform rash caused by EGFR inhibitors, based on an experts' Delphi consensus.

Methods:

The initiative was led by five members of the European Academy of Dermatology and Venereology Task Force ‘Dermatology for Cancer Patients’ who developed a questionnaire that was circulated to a group of 32 supportive oncodermatology experts in Europe, Canada, Argentina, the US States and Asia. The questionnaire consisted of 84 statements in total, regarding diagnosis and treatment of EGFRi‐induced acneiform rash. Experts responded to an anonymous 5‐point Likert scale survey. The coordinators collected the first‐round responses that were checked for consensus (≥75% agreement in positive [agree or strongly agree] or in negative [disagree or strongly disagree] vote). The statements that did not reach strong consensus in the first round were revised, according to experts' feedback, for a second‐round survey.

Results:

Strong consensus was reached in 75/84 (89.3%) of the statements, whilst moderate consensus was achieved in 6/84 elements. Key points include consideration of low‐dose isotretinoin for refractory grade II/III acneiform rash, use of topical steroid‐sparing agents like topical pimecrolimus in the maintenance phase and use of doxycycline in either 100 or 200 mg per day as prophylactic treatment. Interestingly, experts did not recommend topical antibiotics, neither for prevention, nor for treatment. Consensus failure in 3/84 objects is mostly related to the lack of robust data on these topics.

Conclusion:

This consensus offers crucial insights often overlooked by radiotherapists, general practitioners, dermatologists and oncologists, and it is expected to improve the management of oncologic patients treated with EGFRi in different settings and continents.

31 Dec 2024·The Journal of dermatological treatment

Targeting the aryl hydrocarbon receptor as a strategy to expand the therapeutic armamentarium in atopic dermatitis

Author: Boguniewicz, Mark ; Silverberg, Jonathan I. ; Hebert, Adelaide A. ; Eichenfield, Lawrence F.

Atopic dermatitis (AD) is an intensely pruritic, chronic, relapsing, inflammatory skin disease that commonly presents in early childhood, but also affects adults, and severely impacts the quality of life of patients and their families.In view of the clin. effectiveness of tapinarof cream demonstratedin inflammatory skin diseases, targeting AhR may offer a novel therapeutic strategy in other diseases, beyond allergies and asthma, involving homeostasis and immune function of epithelial barrier tissues.

News (Medical) associated with Pimecrolimus

04 Feb 2025

·www.businesswire.com

Devonian Health Group Inc. Reports Superior Anti-Inflammatory Potency of Thykamine™ in Comparative In Vitro Study

QUEBEC CITY--( BUSINESS WIRE )--Devonian Health Group Inc. (“ Devonian ” or the “ Corporation ”) ( TSXV: GSD; OTCQB: DVHGF ), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced the results of its in vitro comparative study, which demonstrate the anti-inflammatory effect of Thykamine™, with superior potency on the inflammatory biomarkers as compared to currently marketed anti-inflammatory agents, which included various corticosteroids and a phosphodiesterase inhibitor. The assays were conducted at Department of Microbiology, Infectious Diseases, and Immunology in the Faculty of Medicine at Université Laval (Quebec City) under the leadership of Pr Louis Flamand, PhD, MBA (1) in collaboration with Dr John Sampalis, PhD, Epidemiologist, Medicine Faculty, McGill University and Dr Charles Lynde, MD from Lynde Dermatology and Associate Professor in the Department of Medicine at the University of Toronto. The primary objective of the study was to compare the anti-inflammatory potency of Thykamine™ to other anti-inflammatory agents in the market, specifically betamethasone valerate, clobetasol, crisaborole, 21-acetate hydrocortisone, pimecrolimus and prednisone. The experiment involved treating lipopolysaccharide (LPS) stimulated U937 monocytic cells with each agent. Anti-inflammatory potency was assessed by the percent inhibition of the activity of four cytokines induced by each agent. The four cytokines tested were MCP-1, MIP-1α, MIP-1β and RANTES that have been implicated in several autoimmune diseases. Percent inhibition was calculated as the reduction in lipopolysaccharide (LPS) induced cytokine activity after addition of the agent. Given that the aim of anti-inflammatory drugs is to dampen cytokine induced inflammation, these results can be used as inference to overall anti-inflammatory efficacy. All agents were tested at four increasing concentrations except for pimecrolimus that was tested at three concentrations. All culture conditions were run in hexaplicate (n=6). Cell-free supernatants were collected and immediately assayed for cytokine concentration using Pro-Carta 6 plex (Life Technologies). U937 secreted amounts of IL-6 or IL-10 that were below the detection limits of the assay and were not included in the analyses. When compared to the other agents, Thykamine™ showed clinically important and statistically significant higher inhibition potency for MCP-1 (by 28% to 136%; P< 0.009), MIP-Alpha (by 30% to 108%; P < 0.001), MIP-1 Beta (by 39% to 111%; P < 0.001). For RANTES higher inhibition was observed for all agents (by 47% to 258%) except for Crisaborole and Prednisone. In this assay, pimecrolimus did not inhibit any of the cytokine tested. “ These results support the wide spectrum anti-inflammatory properties of Thykamine™ with potency that is superior to currently marketed anti-inflammatory agents. This study indicates a multi mode of action of Thykamine™ affecting several cytokines and other biomarkers, supporting the clinical efficacy demonstrated in phase 2 studies in ulcerative colitis and atopic dermatitis in adults,” said Dr Louis Flamand, lead study investigator. “ The high potency and previously established clinical efficacy of Thykamine™ , combined with its placebo-like safety, should compel practitioners to consider its use as a first line treatment, especially with the potential safety concerns of the present standard of care,” said Dr Lynde, who was consulted on the current study and was the lead investigator in Devonian’s phase 2 study in adults with mild-to-moderate atopic dermatitis. The study’s co-investigator Dr. John Sampalis, Clinical Epidemiologist, and Professor of Medicine at McGill with extensive experience in the evaluation of treatments for autoimmune disorders commented: “ The results of this in vitro study are extremely encouraging. The favorable safety profile of Thykamine™ as demonstrated in human clinical studies and its high anti-inflammatory potency proven in this study, would position Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease. This can result in steroid sparing effect and reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences.” Investigators of this study are planning to submit the results in a peer-reviewed journal. (1) Pr. Louis Flamand is a director on the board of directors of the Corporation About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). For more information, visit www.groupedevonian.com Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economical impact of clinical study, the efficiency of the high anti-inflammatory potency proven and the position of the Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences, and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.

Phase 2Clinical Result

16 Nov 2023

·synapse.patsnap.com

What are calcineurin inhibitors and how do you quickly get the latest development progress?

CaN or calcineurin iis an assembly of phosphatases comprising a 61-kDa catalytic component that binds with calmodulin (termed calcineurin-A) and a 19-kDa regulatory component that interacts with calcium (known as calcineurin-B). This protein is involved in numerous cellular interactions and pathways for signal transduction dependent on calcium, including the triggering of T cells. Calcineurin inhibitors, in essence, attach with high selectivity to particular intracellular receptors known as immunophilins, which include cyclophilin and FK binding protein. The inhibitory interaction between the drug and its receptor selectively and competitively obstructs the activity of calcineurin, which is stimulated by the release of intracellular calcium following the engagement and co-stimulation of T cell receptors from cells presenting antigens. This action consequently prohibits the progression of a group of transcription factors (NF-AT), causing a decrease in the transcriptional activation of cytokine genes such as interleukin (IL)-2, tumor necrosis factor (TNF)-alpha, IL-3, IL-4, CD40L, granulocyte-macrophage colony-stimulating factor, and interferon-gamma. Via selective inhibition of calcineurin, they obstruct the transcription of interleukin-2 and other cytokines within T lymphocytes thereby disrupting T cell trigger, proliferation and differentiation. Their primary action is on T-helper cells, but this in turn leads to the inhibition of T suppressor and T cytotoxic cells. They serve as immunosuppressants and concurrently, they extend a direct protective effect on podocytes, such as impeding the dephosphorylation of synaptopodin, a pivotal protein managing the actin filaments of the podocyte skeleton, induced by calcineurin. The inhibitors enhance the lifespan of podocytes and diminish their migratory behavior. Novartis AG, Astellas Pharma, Inc., Sun Pharmaceutical Industries Ltd., LEO Pharma A/S, and Aurinia Pharmaceuticals, Inc. are the companies growing fastest under the target Calcineurin, with Novartis AG having the highest number of approved drugs.Dermatitis, Atopic and Graft Rejection are the most common indications with the highest number of approved drugs. Small molecule drugs and synthetic peptides are progressing rapidly under the target Calcineurin, indicating intense competition around the innovative drugs. The United States is leading in the development of drugs targeting Calcineurin, followed by the European Union, China, and other countries. China has shown progress in the development of drugs targeting Calcineurin, with several approved drugs and ongoing preclinical research.Overall, the target Calcineurin presents a competitive landscape with multiple companies, diverse indications, and various drug types. The future development of target Calcineurin is promising, with ongoing research and development efforts in different countries. How do they work?A CaN inhibitor refers to a type of drug or compound that inhibits the activity of the enzyme calcineurin (CaN). Calcineurin is a protein phosphatase that plays a crucial role in various cellular processes, particularly in the immune system. By inhibiting CaN, these inhibitors can modulate immune responses and have potential applications in the treatment of autoimmune diseases, organ transplantation, and certain cancers. From a biomedical perspective, CaN inhibitors are of particular interest in immunology and pharmacology. They can interfere with the signaling pathways involved in immune cell activation, leading to immunosuppression. This property makes them valuable in preventing organ rejection after transplantation and managing autoimmune conditions like rheumatoid arthritis or psoriasis. Additionally, CaN inhibitors have shown promise in certain types of cancer, as they can inhibit the growth and proliferation of cancer cells. It's important to note that the specific mechanism of action and side effects of CaN inhibitors may vary depending on the particular drug or compound being used. Therefore, it is crucial to consult with a healthcare professional for accurate and detailed information regarding the specific CaN inhibitor in question. List of Calcineurin InhibitorsThe currently marketed CaN inhibitors include: VoclosporinCyclosporine (Huons)PimecrolimusTacrolimus liposomalTacrolimusCyclosporineCiclosporin liposomalAzasetron besylateDLQ-02Plerixafor/TacrolimusFor more information, please click on the image below. What are Calcineurin inhibitors used for?Inhibitors of Calcineurin are used as an immunosuppressive treatment for autoimmune diseases like lupus nephritis, idiopathic inflammatory myositis, interstitial pulmonary disorders, atopic dermatitis, among others. For more information, please click on the image below to log in and search. How to obtain the latest development progress of Calcineurin inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of CaN inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

12 Jan 2023

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ATOPIC DERMATITIS IN ADULTS WITH TOPICAL THERAPIES

Both well-established and newer topical treatments addressed ROSEMONT, Ill., Jan. 12, 2023 /PRNewswire/ -- Often called eczema or atopic eczema, atopic dermatitis is a common skin condition, affecting 1 in 10 Americans1. Although atopic dermatitis occurs most frequently in children, it also affects adults and can have a significant impact on patients' quality of life. To help ensure that adult patients with atopic dermatitis receive the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies in the Journal of the American Academy of Dermatology. Continue Reading This is the second in a series of updated guidelines the AAD is producing on the condition. The updates, which outline best practices for topical treatment of the disease, were developed by an expert workgroup of 12 physicians, including 11 dermatologists, an allergist/pediatrician and one patient representative. The AAD published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies Tweet this "Atopic dermatitis is the most common type of eczema, and it can interfere with a person's daily life without proper treatment," said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis." Atopic dermatitis can develop on any area of your skin at any age. Adults who have atopic dermatitis often have red to dark patches and scaly skin. They also can have extremely dry skin, hand eczema, eye problems, and skin that is easily irritated. "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," said Dr. Sidbury. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety." The Atopic Dermatitis Workgroup developed 12 recommendations on how to manage atopic dermatitis in adults with topical therapies. The workgroup provided new recommendations for non-prescription methods as well as prescription treatments. Strong recommendations were made for topical treatments in which the benefits clearly outweigh the risks and burdens to the patient. These recommendations apply to most patients in most circumstances. Strong recommendations were made for the use of the following: Moisturizers help to relieve patients' dry, cracked skin, decrease inflammation, and reduce the severity of and increase the time between flare-ups. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) reduce patients' inflammation and itching, as well as decrease their flare-ups. Topical corticosteroids are commonly used as the first-line treatment for patients with atopic dermatitis in all skin regions. They help to relieve itching, decrease inflammation, and can decrease infections. Phosphodiesterase-4 inhibitor (crisaborole ointment) can reduce patients' inflammation, help relieve itching, and decrease infections. Janus kinase inhibitor (ruxolitinib cream) can be used short term to ease the inflammation and itching of patients with mild to moderate atopic dermatitis. The guidelines provide conditional recommendations for the use of bathing and wet wrap therapy. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Bathing, followed by moisturization , helps patients hydrate the skin. Bleach baths can help patients prevent infection and get rid of bacteria on their skin. Wet wrap therapy utilizes wet bandages to help hydrate and soothe patients' skin. This treatment provides a barrier against scratching, helps to decrease redness and inflammation, and can reduce the bacteria on patients' skin. "These recommendations are based on the latest evidence-based research on the most effective topical treatments for our patients," said Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "These recommended treatments can be used individually or in combination with other treatments." The guidelines made conditional recommendations against the use of topical antimicrobials, antiseptics, and antihistamines due to the low certainty of evidence, which means the true effect may be substantially different from the estimated effect. "These guidelines were updated to enable dermatologists to optimize topical treatments to provide adult atopic dermatitis patients with expert care," said board-certified dermatologist Mark D. Kaufmann MD, FAAD, president of the AAD. "Since each patient's atopic dermatitis is unique, board-certified dermatologists can determine the treatments that will work best for them. I'm very grateful to our workgroup for providing these important updates to help patients worldwide." To find a board-certified dermatologist in your area, visit aad.org/findaderm. More information: Eczema Types: Atopic Dermatitis Overview Eczema Types: Atopic Dermatitis Symptoms Guidelines of care for the management of atopic dermatitis in adults with topical therapies About the AAD 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,000 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, Pinterest and YouTube and @AADskin1 on Instagram. About JAAD The Journal of the American Academy of Dermatology is the most widely read dermatology journal in the world, according to Kantar Media. JAAD was the first most-cited dermatology journal in 2021, according to impact factor rankings from Clarivate's Journal Citation Reports (JCR) Web of Science Group. JAAD also has two open-access companion titles: JAAD Case Reports and JAAD International. Follow @JAADJournals on Facebook, Twitter, and Instagram. SOURCE American Academy of Dermatology

100 Deals associated with Pimecrolimus

External Link

KEGG	Wiki	ATC	Drug Bank
D05480	Pimecrolimus	D11AH02	DB00337

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Eczema	China	Novartis Pharma AG	29 Sep 2005
Dermatitis, Atopic	United States	Bausch Health US LLC	13 Dec 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Blepharitis	Phase 3	United States	Famy Life Sciences Pvt Ltd.	22 Apr 2024
Dermatitis, Perioral	Phase 3	Germany	Novartis AG	01 Sep 2005
Chronic dermatitis	Phase 3	-	Novartis AG	01 Jul 2004
Mild Atopic Dermatitis	Phase 3	United States	Meda Pharma GmbH & Co. KG	01 Apr 2004
Mild Atopic Dermatitis	Phase 3	Germany	Meda Pharma GmbH & Co. KG	01 Apr 2004
Moderate Atopic Dermatitis	Phase 3	United States	Meda Pharma GmbH & Co. KG	01 Apr 2004
Moderate Atopic Dermatitis	Phase 3	Germany	Meda Pharma GmbH & Co. KG	01 Apr 2004
Severe Atopic Dermatitis	Phase 3	Germany	Novartis AG	01 Dec 2001
Dermatitis, Seborrheic	Phase 2	United States	Novartis AG	07 May 2007
prurigo nodularis	Phase 2	Germany	Novartis Pharmaceuticals Corp.	01 Apr 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCD2023	Not Applicable	Dermatitis, Atopic	-	Pimecrolimus	bkqyitalcx(riuzzmpsoa) = for at least three months qkeeyqfazi (odqyhhsobw )	Positive	03 Jul 2023
ACAAI2022	Not Applicable	Dermatitis, Atopic	-	Topical Pimecrolimus	piiuhdaqqt(enwhruthbu) = admrtsmjad bbumpusfit (dbxifnjwfg )	Positive	10 Nov 2022
				Topical Tacrolimus	piiuhdaqqt(enwhruthbu) = eczsenojfz bbumpusfit (dbxifnjwfg )
NCT00120523 (PETITE study, EADV2022)	Phase 3	Dermatitis, Atopic	120	Pimecrolimus 1% cream	ldnicqqsbw(qovbrinwuv) = The most frequently reported AEs (≥ 30% in any treatment group) are listed in Table-1. These AEs were reported by similar proportions of patients treated with PIM or TCS. wlhkmxdmgn (gpxkqdwsoa )	-	07 Sep 2022
				Topical corticosteroids (TCS)
NCT00403559 (CTgov)	Phase 2	Dermatitis, Seborrheic	113	Elidel (Elidel Cream (Pimecrolimus))	jqyknxzuni = epnfnbzodb fnaqpjgdsc (autphlvilb, xtktwbamev - zntovrkkkd)	-	14 Mar 2022
				Ketoconazole Cream (Ketoconazole Cream (Nizoral))	jqyknxzuni = ohiyoseytc fnaqpjgdsc (autphlvilb, dlzoadcwlv - lghqfxkgew)
NCT02791308 (CTgov)	Phase 3	Dermatitis, Atopic	587	Pimecrolimus Cream, 1% (Pimecrolimus Cream, 1%)	jlqzbxkyas = xhkivnwypi tuefwcytyp (ddrsxmcapj, fgnyamcrbv - qmpybimvva) View more	-	24 Apr 2020
				Pimecrolimus (Elidel Cream, 1%)	jlqzbxkyas = tqpatkjadl tuefwcytyp (ddrsxmcapj, olxtkqjrnr - vzfcvluqnl) View more
NCT03107611 (CTgov)	Phase 3	Moderate Atopic Dermatitis \| Mild Atopic Dermatitis	654	Pimecrolimus Cream, 1% (Test)	lzzeuwsqpv = brlnliislt dfujhrvdur (phaynirhia, xwfqejgfpa - hjsiqqjvtg) View more	-	17 Mar 2020
				Pimecrolimus Cream, 1% (Reference Standard)	lzzeuwsqpv = jximpikmvz dfujhrvdur (phaynirhia, njdbmitmqn - elokzzolei) View more
NCT01692626 (CTgov)	Phase 2	Exanthema	13	sidePimecrolimus (Left sidePimecrolimus Cream)	djoehyinux = qbwxsklzfx elgirlcuho (ltealvjflv, mybkfotvmc - ekjbbiizel)	-	15 Mar 2017
				Pimecrolimus Cream (The Right Side the Pimecrolimus Cream)	djoehyinux = jkpvkbuola elgirlcuho (ltealvjflv, rfhuycearr - ieeacpjspq)
NCT00120523 (Pubmed \| Pediatrics) Manual	Phase 3	Dermatitis, Atopic First line	2,418	pimecrolimus	brcjqfxduk(bppraliohj) = cgcyhjovkz mlggarjqnb (qtecrjwzwb ) View more	Similar	01 Apr 2015
				topical corticosteroids	brcjqfxduk(bppraliohj) = bldnlqtqlu mlggarjqnb (qtecrjwzwb ) View more
NCT00208026 (CTgov)	Phase 1/2	Netherton Syndrome	3	Pimecrolimus Cream (Patient 1)	dpqsusztxm = uitzpyoamv lvaaokqutd (zwputaxrzt, fhpzzbywuv - xbqpyejfxe) View more	-	12 Dec 2014
				Pimecrolimus Cream (Patient 2)	dpqsusztxm = qoxdharoxg lvaaokqutd (zwputaxrzt, wzrfxuqqoj - ypucbuwbzz) View more
NCT00946478 (CTgov)	Not Applicable	Eczema \| Dermatitis, Atopic	40	Pimecrolimus (Pimecrolimus)	dzkfkpiipg(vhtjkncgki) = bsktxwefox qyrxqzcvdf (batdmfowbk, .002) View more	-	10 Mar 2014
				Vehicle cream (Vehicle Cream)	dzkfkpiipg(vhtjkncgki) = rsszdwsnfu qyrxqzcvdf (batdmfowbk, .004) View more

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