The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:
• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.
Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.
Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Start Date24 Feb 2024

Sponsor / Collaborator-

CTRI/2024/02/062423 / Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Topical Adapalene(0.1%W/W) & CLINDAMYCIN(1%W/W) versus Topical Adapalene(0.1%W/W) & Benzoyl peroxide(2.5%W/W) in Inflammatory Acne Vulgaris: A Comparative study

Start Date16 Feb 2024

Sponsor / Collaborator-

NCT05582434 / RecruitingEarly Phase 1IIT

Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

Start Date15 Feb 2024

Sponsor / Collaborator

Wake Forest School of Medicine

[+1]

100 Clinical Results associated with Adapalene

100 Translational Medicine associated with Adapalene

100 Patents (Medical) associated with Adapalene

603

Literatures (Medical) associated with Adapalene

18 Oct 2024·Dermatology and Therapy

Epidemiology and Healthcare of Juvenile and Late-Onset Acne: Claims Data Analysis.

Article

Author: Hagenström, Kristina ; Klinger, Theresa ; Stephan, Brigitte ; Augustin, Matthias ; Müller, Katharina

INTRODUCTION:

Acne is the most frequent chronic inflammatory skin condition in adolescence but occurs also in later age. Our study aimed to characterise the epidemiology, geographical distribution, comorbidity and healthcare of acne juvenilis (AJ) and acne tarda (AT).

METHODS:

Statutory health insurance (SHI) data from 2016 to 2020 were analysed. Prevalence rates, including geographical distribution, comorbidities and drug use by specialists group, were measured.

RESULTS:

In 2020, the prevalence of acne among adults was 1.50% (AT > 25 years) and among adolescents was 3.88% (AT ≤ 25 years). The highest prevalence (13.02%) was observed at the age of 17 years. Sex differences were higher in AT (73.80% in women) than in AJ (64.55% in women). Compared with non-affected persons, individuals with acne - in particular with AT - showed significantly higher rates of skin-related comorbidities, including folliculitis (rate ratio (RR) 8.89), pyoderma (RR 7.27) and rosacea (RR 5.53), and non-skin-related comorbidities, such as ovarian dysfunction (RR 2.36), rhinitis allergica (RR 1.84) and Crohn's disease (RR 1.79). Preferred systemic therapeutics prescribed were anti-infectives in AT (46.86%) and retinoids in AJ (52.35%). In the majority of cases, dermatologists were involved in the treatment of acne (AT 65.77%; AJ 76.27%). The most commonly prescribed topical agents were adapalene with benzoyl peroxide (AT 87.72%; AJ 85.75%), while systemic isotretinoin (AT 81.20%; AJ 90.06%) was also a frequently used drug. General practitioners were more likely to prescribe anti-infectives, especially topical antibiotics such as chlortetracycline (AT 52.38%; AJ 44.44%) and systemic antibiotics, especially tetracycline (AT 58.33%; AJ 67.50%).

CONCLUSION:

Acne affects a relevant proportion of the German population not only in adolescence, and management of this inflammatory skin disease does not naturally follow medical guidelines or specialist recommendations. These findings emphasise the importance of specialised care and comprehensive therapeutic management that should also consider the exploration of comorbidities.

01 Oct 2024·Journal of Drugs in Dermatology

Application Characteristics and Patient Preference of Triple-Combination vs Layered Topicals for Acne: Split-Face Study.

Article

Author: Draelos, Zoe D

BACKGROUND:

Although triple-combination therapies for acne are generally more efficacious than dual-combinations or topical monotherapy, this benefit may be offset by reduced adherence to a complicated treatment regimen. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB; Cabtreo®, Ortho Dermatologics) gel is the first triple-combination topical approved for the treatment of acne. By delivering multiple active ingredients as a fixed-dose combination, CAB gel may improve ease of use, which can benefit both treatment adherence and efficacy. The objective of this study was to compare the application characteristics of CAB gel with the layered application of its 3 individual active ingredients.

METHODS:

In this split-face study, adults with acne-prone skin (N=25), self-applied CAB gel (0.3 cc) to 1 side of the face and layered benzoyl peroxide cream, adapalene gel, and clindamycin gel (0.1 cc each) on the opposite side. CAB and clindamycin gels were compounded with pyranine, which fluoresces under blue light. Photos taken under blue light were used to assess the uniformity of product application, and participants rated the evenness, speed, and ease of the 2 application regimens, as well as overall preference.

RESULTS:

Investigator-assessed evenness of application favored CAB gel over layered application in 100% of participants. All participants rated the application of CAB gel as more uniform, easier, and faster. Most (96%) preferred CAB gel for use at home.

CONCLUSION:

Fixed-dose CAB gel was applied more evenly than separate application of its 3 active ingredients. By addressing 3 of the main acne pathogenic pathways in a single, easy-to-apply formulation, CAB gel may improve the efficacy of and adherence to acne treatment. J Drugs Dermatol. 2024;23(10):857-861. doi:10.36849/JDD.8430.

01 Oct 2024·Journal of Drugs in Dermatology

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

Article

Author: Baldwin, Hilary ; Harper, Julie C ; Rosso, James Q Del ; Guenin, Eric ; Bhatia, Neal ; Lain, Edward Ted ; Feldman, Steven R ; Gold, Linda Stein ; Bunick, Christopher G ; Kircik, Leon

BACKGROUND:

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB.

METHODS:

In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.

RESULTS:

At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P<0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed.

CONCLUSIONS:

CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne. J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484.

News (Medical) associated with Adapalene

25 Oct 2024

·www.prnewswire.com

Studies Show Sun Pharma's WINLEVI® (clascoterone) Cream 1% Reduces Sebum Levels and is Suitable for Combination With Other Commonly Used Topical Acne Medications

WINLEVI poster presentations at 2024 Fall Clinical Dermatology Conference also include data affirming reduced acne severity and tolerability in patients with skin of color. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or associate companies), today presented data strengthening the clinical rationale for the use of WINLEVI ® (clascoterone) cream 1% to treat acne. In poster presentations at the 44th Annual Fall Clinical Dermatology Conference, data show WINLEVI significantly reduces sebum (oil) production and demonstrates excellent stability in the presence of other commonly prescribed topical acne treatments, supporting the use of WINLEVI in combination with those medications. Data also showed patients with skin of color, an under-represented population in studies of acne medications, experienced reduced acne severity and tolerability while taking WINLEVI. Collectively, the data continue to show that WINLEVI improves acne severity and is well tolerated. "As we learn more about the importance of sebum as a main cause of acne, it is gratifying to see new data supporting the use of WINLEVI to reduce sebum production as well as its suitability for combination treatment with other commonly prescribed topical agents," said Abhay Gandhi, chief executive officer, North America at Sun Pharma. "We are also encouraged by the reported reductions in acne severity and tolerability in people with skin of color, for whom the impact of acne can be profound. Together, these latest studies further establish WINLEVI as a safe and effective acne medication that dermatology professionals can confidently prescribe to their patients." WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older, and the first and only FDA-approved topical treatment available in the U.S. that targets sebum production in the skin. Sebum is an oily wax that protects and moisturizes skin, but too much of it feeds bacteria inside the skin, causing inflammation and acne lesions. Acne is the most prevalent skin condition in the U.S., affecting up to 50 million Americans and 80% of people at some point during their lives.1,2 It is the most common dermatological disorder in Black/African American and Hispanic/Latino populations.3 WINLEVI cream is a topical prescription medicine to treat acne in people 12 and older. The most common side effects include reddening, scaling or dryness, and itching. Local irritation may occur. Sebum reduction data Researchers presented 12-week interim results from a yearlong study of the effect of WINLEVI on facial sebum production in patients with acne. The study's primary objective and efficacy endpoint was reduction in casual facial sebum levels, as measured by a sebumeter, a device that directly measures the amount of lipids on the skin's surface. The study was also designed to assess the ability of WINLEVI to reduce the Investigator's Global Assessment (IGA) score, a scale designed for investigators to assess the level of facial acne (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Other study objectives and efficacy endpoints included inflammatory and noninflammatory acne lesion counts, and investigator-assessed oily appearance, pore size, and facial shine; the latter three endpoints were assessed on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Among the 40 participating patients, the mean age was 20.9 years; most patients were female (60%) and White (63%). All patients entered the study with mild (57.5%) or moderate (42.5%) acne, as well as a mean sebumeter reading of 115.9 ± 50.5. The researchers reported significant reductions in sebumeter measurements following use of WINLEVI at six (-22%, P = 0.002), 10 (-19%, P = 0.005), and 12 weeks (-27%, P <0.001). They also observed significant improvements in facial oily appearance after four weeks of WINLEVI treatment (-8%, P = 0.008), with continued improvement through 12 weeks (-40%, P <0.001). Similarly, patients' pore size improved significantly after six weeks (-13%, P = 0.002), and continued to improve through 12 weeks (-23%, P <0.001). Additionally, facial shine levels significantly improved after four weeks (-9%, P = 0.004) with continued improvement through 12 weeks (-39%, P <0.001). By Week 12, patients using WINLEVI experienced a statistically significant 29% reduction in IGA score (P <0.001). Use of WINLEVI also resulted in significant reductions in the numbers of inflammatory and noninflammatory lesions (-48% and -40%, respectively; P <0.001 for both measurements) after four weeks, with continued improvement through 12 weeks (-54% and -34%, respectively; P <0.001 for both). WINLEVI was well tolerated through Week 12, with no reports of adverse reactions. "This is exciting news for people living with acne because this is the first study to demonstrate a reduction in measured facial sebum production following the use of clascoterone cream 1%," said lead investigator Zoe D. Draelos, MD, of Dermatology Consulting Services, PLLC, in High Point, N.C. "In addition to confirming the sebum-reducing effect of WINLEVI, our findings support data from previous clinical trials which showed reductions in the number of inflammatory and noninflammatory lesions, further demonstrating the clinical utility of this topical acne medication." Stability in combination therapy data Dr. Draelos and colleagues also reported results from a study assessing the stability of WINLEVI when layered with other topical acne medications such as tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and benzoyl peroxide encapsulated 5%. Each of these medications were placed separately on individual microscope slides with WINLEVI and incubated for eight hours at 37° Celsius. Material from the slides was extracted for analysis via high-performance liquid chromatography-mass spectrometry (HPLC-MS). WINLEVI concentrations remained stable after layering with other acne medications. The percentage of WINLEVI recovered after layering ranged from 98% to 119%, indicating that none of the acne medications evaluated induced degradation of WINLEVI when used in combination. "Multimodal topical therapy, incorporating products with multiple mechanisms of action to target multiple mechanisms of disease, has become standard practice in the treatment of acne," commented Dr. Draelos. "In this in vitro study, WINLEVI demonstrated consistent and reproducible stability in the presence of other acne medications. Our findings support the combination of WINLEVI with topical retinoids, topical antibiotics, and/or benzoyl peroxide as a viable acne treatment strategy and complement the encouraging results observed in the sebum reduction and skin of color trials." Skin of Color Data A separate team of researchers presented 16-week interim results from a 56-week, single-center, open-label pilot study evaluating the efficacy and safety of WINLEVI in 10 patients (mean age 24 years) with skin of color (Fitzpatrick skin types IV, V, and VI) and moderate-to-severe facial acne. The study met its primary endpoint, with seven (78%) patients achieving an IGA score of 0 (clear) or 1 (almost clear) at Week 16 (P = 0.008 vs. baseline). The study also met its secondary endpoints at Week 16, including significant reductions in inflammatory (91.8%, P = 0.008), noninflammatory (90.9%, P = 0.009), and total lesions (90.9%, P = 0.009). Investigator- and participant-assessed tolerability parameters were absent or minimal at most time points through Week 16. There were no reports of adverse events during the 16-week interim analysis period. For complete prescribing information please click here. INDICATION WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the pharmacokinetics (PK) trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops. Pediatric patients may be more susceptible to systemic toxicity. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects. ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References 1 Skin conditions by the numbers. American Academy of Dermatology Association, 2021. Available at Skin conditions by the numbers (aad.org). Accessed January 11, 2023. 2 Collier CN, Harper JC, Cafardi JA, et al. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008;58(1):56-59. 3 Taylor SC. Epidemiology of skin diseases in people of color. Cutis. 2003;71(4):271-275. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug Approval

31 Jan 2024

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ACNE

Both newly approved and well-established treatments recommended ROSEMONT, Ill., Jan. 31, 2024 /PRNewswire/ -- Acne is the most common skin condition in the United States, affecting nearly 50 million Americans each year, with symptoms usually beginning in puberty. Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. To help ensure that people with acne get the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of acne in adults, adolescents, and children over the age of 9 in the Journal of the American Academy of Dermatology. Continue Reading "These guidelines provide important updates to the 2016 AAD acne guidelines, including discussion of new topical medications, which are directly applied to the skin, and systemic treatments, which are taken by mouth," said board-certified dermatologist John S. Barbieri, MD, MBA, FAAD, co-chair of the AAD's Acne Guideline Workgroup. "This update provides evidence-based recommendations for dermatologists and other clinicians caring for patients with acne." Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. Post this Updates to the management of acne vulgaris provides 18 evidence-based recommendations for topical, systemic, and physical treatment methods, including newly approved therapeutic options, and 5 good practice statements. Strong recommendations were made for the use of the following: Topical benzoyl peroxide to reduce the amount of acne-causing bacteria on the skin. Topical retinoids (e.g. adapalene, tretinoin, tazarotene, trifarotene) to help unclog pores and reduce inflammation. Oral antibiotics, such as oral doxycycline, and topical antibiotics to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Combinations of topical benzoyl peroxide, retinoids, or the above antibiotics. Employing best practices in guideline development, the multidisciplinary workgroup also issued 5 good practice statements. When managing acne with topical medications, the guidelines recommend combining multiple different treatment types, as this can lead to better results. The guidelines recommend limiting use of oral antibiotics when possible to reduce the development of antibiotic resistance and other antibiotic-associated complications. It is recommended that topical and oral antibiotics are used simultaneously with benzoyl peroxide to prevent the development of antibiotic resistance. For patients with larger acne bumps, the guidelines recommend injectable corticosteroids as a potential option for more rapid relief of inflammation and pain. For patients with severe acne or for patients who have failed standard treatment with oral or topical therapy, the guidelines recommend isotretinoin. Additionally, the guidelines provide conditional recommendations. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Topical clascoterone, which addresses hormonal causes of acne. Topical salicylic acid to unclog pores and exfoliate the skin. Topical azelaic acid to unclog pores, kill bacteria, and fade dark spots that may continue when an acne spot clears. Oral minocycline or sarecycline to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. Available evidence was insufficient to develop recommendations for procedures such as chemical peels, laser and light-based devices, microneedling, as well as for dietary changes, or alternative therapies such as vitamins or plant-based products. Additionally, a conditional recommendation against adding broadband light, intense pulsed light, to adapalene 0.3% gel. "Board-certified dermatologists are on the forefront of new and exciting advances in the treatment of acne," said Dr. Barbieri. "We are able to offer our patients with acne more options than ever before as we work to address their concerns and determine the most effective treatment plan possible. Just as important, dermatologists must have access to all available therapeutic options." Since there are a variety of treatment options for acne and treatment plans are not one-size-fits-all, it is important to partner with a board-certified dermatologist to decide which options work best for you. To find a board-certified dermatologist in your area, visit aad.org/findaderm. More Information Acne resource center Acne treatment AAD B-Roll Library About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 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, TikTok, Pinterest and YouTube and @AADskin1 on Instagram. SOURCE American Academy of Dermatology

30 Jan 2024

·www.biospace.com

CABTREO(TM) (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris Now Available in the U.S.

LAVAL, QC / ACCESSWIRE / January 30, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its dermatology business, Ortho Dermatologics, today announced the U.S. launch of CABTREO™ (clindamycin, adapalene, benzoyl peroxide) Topical Gel, 1.2%/0.15%/3.1% indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. "With today's launch of CABTREO, millions of Americans who suffer from acne each year have access to a new once-daily triple-combination topical acne treatment," Thomas J. Appio, Chief Executive Officer, said. "In many instances, acne treatment requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen." CABTREO Topical Gel is the first and only U.S. Food and Drug Administration-approved fixed-dose, once-daily triple-combination topical treatment for acne and offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. The FDA approved CABTREO Topical Gel on Oct. 20, 2023, based on data from two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated CABTREO Topical Gel resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. At week 12, 50.0% of participants achieved treatment success with CABTREO versus 22.6% with vehicle gel (P<0.001). CABTREO resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9%% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P<0.001, both). The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis. About Acne Vulgaris Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2 What is CABTREO? CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina. IMPORTANT SAFETY INFORMATION Do not use CABTREO if you have had an allergic reaction to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any of the ingredients in CABTREO or have Crohn's disease, ulcerative colitis, inflammation of the colon (colitis), or severe diarrhea with antibiotic use. Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and if you take or use a medicine that contains erythromycin. CABTREO should not be used with products that contain erythromycin. What should I avoid while using CABTREO? Avoid or limit your time in sunlight, including use of sunlamps or tanning beds during treatment with CABTREO as it can make you more sensitive, and you could get severe sunburn. Use sunscreen and wear clothes including a hat that covers the treated areas of your skin if you have to be in sunlight. Cold weather and wind may irritate skin treated with CABTREO. Avoid applying CABTREO to areas with skin problems including, cuts, abrasions, sunburned skin, or eczema. Avoid skin products that may dry or irritate your skin. Avoid the use of "waxing" as a hair removal method on skin treated with CABTREO. What are the possible serious and most common side effects of CABTREO? Tell your doctor right away if you experience side effects, including: Allergic reactions: Stop using CABTREO if you have hives, rash, severe itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, throat tightness, feeling faint, dizzy, or lightheaded. Inflammation of the colon (colitis): Stop using CABTREO if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with CABTREO. Sensitivity to sunlight. See "What should I avoid while using CABTREO". Skin irritation at the application site is common with CABTREO and may include redness, scaling, dryness, stinging, burning, itching, and swelling. These are not all the possible side effects of CABTREO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA- 1088 or Please click here for full Prescribing Information, Patient Information and Instructions for Use. About Ortho Dermatologics Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at . About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Forward-Looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. References 1. American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from . Accessed March13, 2023. 2. Mayo Clinic. (2020). Acne. Retrieved from . Accessed March 13, 2023. Investor Contact: ir@bauschhealth.com (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (848) 541-3785 ### CABTREO™ is a trademark of Ortho Dermatologics' affiliated entities. Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities. © 2024 Ortho Dermatologics' affiliated entities. CAB.0025.USA.24 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

Phase 3Clinical ResultDrug Approval

100 Deals associated with Adapalene

External Link

KEGG	Wiki	ATC	Drug Bank
D01112	Adapalene	D10AD03	DB00210

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	US	Galderma Laboratories LP	31 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Photodamaged skin	Phase 3	BR	Galderma Brasil Ltda.	01 Jan 2013
Skin aging	Phase 3	BR	Galderma Brasil Ltda.	01 Jan 2013
Atrophic acne scar	Phase 2	US	Galderma Holding SA	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03615768 (CACTUS, Pubmed) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	pfgkcrykhr(srmrvaqpym) = ayjndpanqi vzzlsoyyrh (gcbhyqggxm ) View more	Positive	01 Nov 2024
				Adapalene gel	pfgkcrykhr(srmrvaqpym) = metxwszmia vzzlsoyyrh (gcbhyqggxm ) View more
NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	pmhxhsykji(qqwgonpuam) = cuqgyseffx yskiuxyxax (kgnabyhpwj, yoonxzcgyn - agssttkacn) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	pmhxhsykji(qqwgonpuam) = aywtnyvyet yskiuxyxax (kgnabyhpwj, tvxjayeknm - qdkolbwihm) View more
AAD2023	Not Applicable	-	-	Adapalene 0.1% gel	jjrnzaatae(svisevgiki) = gqnroxfuyh hqveeetsfx (oxnxzilqfc ) View more	-	17 Mar 2023
				Tretinoin	jjrnzaatae(svisevgiki) = zmuxupufda hqveeetsfx (oxnxzilqfc ) View more
EADV2022	Not Applicable	Moderate to severe acne	47	Dapsone 7.5% gel	lwbmnrgbwd(hfzfingdcq) = fmxlivjwei vlqcvzlefi (frxlnlajiu ) View more	Positive	12 May 2022
				Adapalene 0.1% gel	lwbmnrgbwd(hfzfingdcq) = vglmjdocxx vlqcvzlefi (frxlnlajiu ) View more
NCT02525549 (CTgov)	Phase 3	Acne Vulgaris	903	Adapalene+Benzoyl Peroxide Gel (Test Product)	cwnxwipdzy(fckxdxxcbs) = ezlgwwmgzx ahhigwwbtl (mcddhpsfmh, geuhblposp - hacygicjyb) View more	-	20 Jan 2021
				Adapalene (Reference Product)	cwnxwipdzy(fckxdxxcbs) = plokihwdjm ahhigwwbtl (mcddhpsfmh, khicmctgep - flkursbcgx) View more
NCT03393494 (CTgov)	Phase 3	Acne Vulgaris	825	Adapalene+Benzoyl Peroxide Topical Gel (Perrigo Active)	stnbmwrebh(cbtnxyrits) = ayvbkeptnj xozpmgzavd (tazhrngbtx, kpphhndxwe - quwhpglbxt) View more	-	05 Jan 2021
				Epiduo Topical Product (Reference Active)	stnbmwrebh(cbtnxyrits) = prjegbngiz xozpmgzavd (tazhrngbtx, aahzjmjcdd - rufuryymrx) View more
NCT02651220 (CTgov)	Phase 3	Acne Vulgaris	1,001	Adapalene+Benzoyl Peroxide Gel (Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w)	gpwtmxhijf(kmuwsuyxos) = ivthwbzjbk zktvsbdwca (dtddkphijh, tmdeoitygg - kaucmstmys) View more	-	23 Jun 2020
				Epiduo® Forte Gel (Epiduo® Forte Gel 0.3%/2.5% w/w)	gpwtmxhijf(kmuwsuyxos) = stdkspfkec zktvsbdwca (dtddkphijh, atsvqnoszk - ipxklmbdev) View more
ERS2018	Not Applicable	Skin Diseases First line EGFR-activating mutations	-	Adapalene	tefraqepal(chnyooqlea) = cytocsqdzo srthmcpofc (fguxoywcaq )	Positive	15 Sep 2018
				Erlotinib+TNF-a+IL-1b	tefraqepal(chnyooqlea) = bqtfwftjdg srthmcpofc (fguxoywcaq )
NCT00671749 (CTgov)	Phase 4	Acne Vulgaris	100	Differin+Duac	phgglcmeek(zsvmlseuhx) = iyoefpbelg xjwikzqfut (kovxrmsxij, nydfhjtagv - vjtjcyvvwi) View more	-	16 Mar 2016
NCT01213199 (CTgov)	Phase 2	Atrophic acne scar	20	Differin	nphrtwqswn(msnorajiut) = xghjxwuyqj teehntrucm (jpdlkmrewp, ltjaqvsivh - mrzovwdsyu) View more	-	23 Mar 2015

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