There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.
Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.
Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).
Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.
Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.

Start Date15 Aug 2026

Sponsor / Collaborator

Khyber Teaching Hospital

NCT07016360

/ RecruitingPhase 4IIT

Comparison of Efficacy of Topical Adapalene Gel Versus Cryotherapy in Recurrent Plantar Warts

This is a comparative study between two treatment options for skin viral infection.

Start Date15 Sep 2025

Sponsor / Collaborator

Khyber Teaching Hospital

NCT07102186

/ RecruitingPhase 4IIT

Comparing the Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris: An Open-label Randomized Controlled Trial.

Acne vulgaris affects around 85% of adolescents and young adults. Adapalene, a topical retinoid, is a common treatment but often causes irritation, leading to poor adherence. Hyaluronic acid (HA), known for its hydrating and anti-inflammatory properties, may help reduce these side effects.
This prospective, open-label, randomized controlled trial compares adapalene 0.1% gel combined with HA serum versus adapalene alone over 8 weeks in patients with mild to moderate acne. Key outcomes include acne lesion reduction, incidence and severity of side effects (erythema, dryness, scaling, stinging/burning, pruritus), and skin hydration assessed through the skin turgor test. Acne severity will be measured using the Acne Severity Index (ASI) and Investigator's Global Assessment (IGA) scale.
The study anticipates better efficacy, reduced irritation, and improved skin hydration with the combination therapy. Ethical approval was obtained, and informed consent will be secured from all participants.

Start Date21 Jul 2025

Sponsor / Collaborator

Badr University In Cairo

100 Clinical Results associated with Adapalene

100 Translational Medicine associated with Adapalene

100 Patents (Medical) associated with Adapalene

705

Literatures (Medical) associated with Adapalene

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies

Article

Author: Tanghetti, Emil A. ; Wroblewski, Karol ; Ghannoum, Mahmoud ; Harper, Julie C. ; Kircik, Leon H. ; Baldwin, Hilary ; Draelos, Zoe D. ; Gold, Linda Stein

AIM:

Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only approved triple-combination acne topical-and its effects on scarring/dyspigmentation in participants with moderate to severe acne.

MATERIALS AND METHODS:

Data were pooled from 2 identical, open-label, single-center studies conducted in participants (N = 50) aged ≥12 years with Investigator's Global Assessment (IGA) score of 3/4. Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and scarring. Adverse events and tolerability (itching, burning, redness, swelling) were assessed.

RESULTS:

At week 24, 67% of participants achieved treatment success, and significant reductions from baseline in inflammatory (88%) and noninflammatory (68%) lesions were observed (p < 0.001, both). Significant reductions in scarring (33%), investigator- and participant-assessed PIH (71%; 78%, respectively), and PIE (77%; 77%, respectively) were demonstrated (p < 0.001, all). Most participants (>70%) reported no tolerability issues throughout the studies. Seven adverse events occurred; 4 were related to CAB, and 3 led to study discontinuation (BPO allergy [n = 2], irritant contact dermatitis to BPO [n = 1]).

CONCLUSIONS:

These findings suggest that CAB is an appropriate and effective topical option for the long-term treatment of acne vulgaris.

28 May 2026·AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE

Pediatric Genital Endemic Kaposi Sarcoma with Partial Response to Adapalene

Article

Author: Agamah, Edem ; Azmi, Farrukh ; Nagendra, Sanjai ; Patel, Ketan ; Furtak, Anastasia

ABSTRACT.:

Kaposi sarcoma (KS) is a human herpesvirus 8 (HHV-8)–associated vascular neoplasm that most commonly affects immunocompromised individuals. Endemic KS occurs in sub-Saharan Africa but rarely involves the anogenital region in pediatric patients. We report a case of a 12-year-old immunocompetent Ghanaian girl presenting with rapidly progressive nodular and fungating masses involving the trunk and external genitalia. Initial biopsies were reported as squamous papilloma; subsequent histopathologic evaluation with immunohistochemistry confirmed nodular-type KS. The patient demonstrated aggressive disease progression with lymphadenopathy and hepatomegaly, and access to systemic chemotherapy was limited because of financial constraints. Treatment with topical adapalene resulted in rapid resolution of smaller cutaneous lesions. This case highlights diagnostic challenges in resource-limited settings and supports the potential role of topical retinoids as a low-cost palliative therapy for cutaneous KS.

10 May 2026·Cureus Journal of Medical Science

Real-World Evaluation of the Episoft® AC Moisturizer With Broad-Spectrum Sunscreen in the Management of Retinoid-Induced Dermatitis: A Retrospective Observational Study

Article

Author: Balasubramanian, Ashwin ; Bhosale, Prajakta ; Gadkari, Rujuta ; Patil, Saiprasad ; Hegde, Swetha ; Nakra, Gaurav ; Bhushan, Sumit ; Dhoot, Dhiraj ; Bala, Sanchaita ; Modi, Ashwini

Background Retinoids are essential in acne management but frequently cause retinoid‑induced dermatitis (RID), characterized by erythema, dryness, burning, and barrier disruption. This study evaluated the real‑world effectiveness and tolerability of Episoft® AC (Glenmark Pharmaceuticals, Mumbai, India), a fixed-dose combination moisturizer with broad‑spectrum sunscreen, in patients experiencing RID. Methods This study was a retrospective, multicentric observational analysis of medical records of acne patients with RID, conducted across 357 dermatology clinics in India, following an independent ethics committee approval (approval no. GSER/2024/BMR-AP/133). The study included 1364 patients who had been prescribed Episoft® AC for managing RID. The mean age was 24.49 years (SD ±5.16), and both male and female participants were included. Subjective symptoms (itching, burning, stinging, tightness) and objective signs (erythema, dark spots, dryness, roughness) were assessed at baseline, Week 2, and Week 4 using a four‑point Likert severity scale. Corneometer‑based skin hydration and adverse events (AEs) were also evaluated. The primary endpoint was reduction in dermatitis symptoms; secondary endpoints were Corneometer-measured skin hydration and overall tolerability. Results A total of 1039 (76%) patients were prescribed a topical retinoid or combination, most commonly 0.1% adapalene + 2.5% benzoyl peroxide (BPO), and 294 (22%) were prescribed oral isotretinoin. Significant improvement was observed across all parameters. By Week 4, complete resolution was reported by 68.7% of patients for itching, by 88.44% for burning, by 69.9% patients for stinging, by 72.63% for tightness, and by 61.69% patients for erythema. In addition, physicians observed significant improvement in dark spots (74.42%), dryness (70.59%), and roughness (73.73%). Hydration improved by 39.91% on Corneometer assessment. AEs were considered predominantly retinoid-associated based on clinical context; definitive causality attribution was not feasible given the retrospective, single-arm, uncontrolled design. Only 1.17% reported mostly mild‑to‑moderate AEs, which were associated with retinoid use. Conclusion Episoft® AC substantially improved the tolerance of topical and systemic retinoid therapy, reducing dermatitis symptoms, enhancing skin hydration, and demonstrating excellent safety. It represents a practical adjunct to support adherence and mitigate RID in routine dermatology practice.

News (Medical) associated with Adapalene

22 May 2026

·www.galderma.com

Galderma receives U.S. FDA approval for Differin® Epiduo® Acne Gel Prescription-to-OTC switch

A unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin® and Epiduo® heritage Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone Zug, Switzerland – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care. With the approval of Differin Epiduo OTC, Galderma is bringing its proven acne science to a broader population of acne sufferers through wider access to a dermatologist-recommended, prescription-strength treatment, while further strengthening its global leadership in acne care. Differin Epiduo is a topical acne treatment that combines adapalene, a third-generation retinoid originally discovered and developed by Galderma to address the stability and tolerability challenges of earlier retinoids, with benzoyl peroxide (0.1/2.5%). This adapalene molecule reflects Galderma’s long-standing leadership in retinoid science, delivering an innovation-led approach that goes beyond traditional OTC acne actives. Together, these two dermatologist-trusted ingredients address key biological drivers of acne – clearing clogged pores, killing acne-causing bacteria, and reducing acne inflammation – to help clear acne, prevent future breakouts and improve skin tone, texture, and overall appearance.1,2 The formulation is further powered by its Simulgel™ Gel Base, which stabilizes and evenly distributes both active ingredients while maintaining benzoyl peroxide’s efficacy and improving overall tolerability. This enables a simple, one-pump, once-daily regimen – a level of ease that is critical to building consistent routines and achieving clearer skin over time. “This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science. Differin Epiduo pairs two complementary, evidence‑based actives: adapalene, a highly stable and well‑tolerated retinoid developed by Galderma, and benzoyl peroxide, a proven antimicrobial agent. This retinoid-benzoyl peroxide combination aligns with dermatology guidelines, which strongly recommend using both together as a first‑line, multimodal approach to acne treatment. Bringing this scientifically grounded combination to the OTC setting allows us to extend that legacy to patients across the U.S. while preserving the clinical rigor that underpins its effectiveness.” BILL ANDRIOPOULOS, PH.D. HEAD OF GLOBAL MEDICAL AFFAIRS GALDERMA Proven efficacy across multiple randomized, controlled Phase 3 studies, with adapalene/benzoyl peroxide gel consistently outperforming adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates (“clear” or “almost clear”).3-5 Clinically meaningful improvement in lesion counts seen as early as Week 1, with antimicrobial activity beginning on Day 1 and up to 70.3% reduction in inflammatory acne lesions at Week 12.3 Sustained efficacy with long‑term use, maintaining ~65% total lesion reduction in a single arm study through 12 months, which supports once‑daily, ongoing acne control.6 Proven efficacy across diverse patient populations, with consistent results and favorable tolerability across skin tones. “This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription. In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.” HEATHER WOOLERY-LLOYD, MD BOARD-CERTIFIED DERMATOLOGIST UNITED STATES First approved as a prescription treatment, Epiduo® (Adapalene 0.1% and Benzoyl Peroxide 2.5%) Gel has been trusted by dermatologists for more than 15 years, with millions of prescriptions written worldwide. Its global clinical legacy includes more than ten Galderma studies involving over 3,200 patients, along with extensive third-party studies, across a wide range of ages, skin tones and acne severity. With this Prescription-to-OTC switch, Galderma continues to play a defining role in shaping modern acne care, leveraging its own proprietary science to advance dermatology, and expanding access to effective treatments. Differin Epiduo will be available over-the-counter at most major retailers, including Walmart, Ulta, Target and Amazon, beginning in the summer of 2026. With a commitment to providing effective solutions across consumers’ acne journey, the Differin portfolio also includes cleansers, treatments, and moisturizers to support and provide wholistic solutions. For more information on Differin Epiduo and other Differin products, please visit www.differin.com and join the Differin community on Instagram, Facebook and YouTube to stay up to date on the latest innovations. * Outside of the U.S. Epiduo® remains a prescription only product. Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ—the skin—meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com. For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Viviana Wiewall Head of U.S. Communications viviana.wiewall@galderma.com +1 786 451 7740 References: Follow us on Social Media for current news and patients stories

Phase 3Drug Approval

23 Apr 2026

·www.adalvo.com

Adalvo and STADA launch Europe's first generic Ivermectin cream in Germany

Adalvo, in partnership with STADA, announces the commercial launch of generic Ivermectin 10mg/g (1%) cream in Germany. It is believed to be the first generic alternative to Soolantra (Galderma) available to patients in Europe. Ivermectin cream is indicated for the treatment of inflammatory lesions – the pimples and spots associated with rosacea, a condition affecting an estimated 5% of the global population, which can significantly impact quality of life. Ivermectin cream, with its dual anti-inflammatory and antiparasitic mechanism of action, has become an important option in managing the condition. The availability of Adalvo’s generic represents a meaningful step towards broader patient access to an established, well-regarded therapy with sustained demand. Working alongside STADA, one of Europe's leading generics and branded medicines companies, Adalvo has delivered on the Day-1 launch ambition. “Through our partnership with Adalvo, we are bringing a high-quality, affordable treatment option to patients in Germany, while equipping physicians and pharmacists with a reliable option to support patient care,” commented Basem Yazgi, General Manager of STADA’s ALIUD PHARMA German generics business. Anil Okay, Adalvo’s CEO, said: “This launch is another great example of the value Adalvo offers our partners: early market entry with a high-quality product that lowers costs for those who are most in need, while helping partners gain a strong foothold.” Adalvo's dermatology portfolio continues to expand, with Ivermectin cream joining Adapalene + Benzoyl Peroxide Gel, Tacrolimus Ointment, and Apremilast film coated tablets. To discuss licensing or commercial opportunities within Adalvo's dermatology portfolio, contact the team today.

Drug Approval

02 Nov 2025

·pharma.economictimes.indiatimes.com

Drugmakers must face skincare drug price-fixing lawsuit, US judge rules

New York: A federal judge on Friday said 36 drugmakers and executives must face nearly all claims in an antitrust lawsuit brought by most U.S. states, accusing them of conspiring to fix prices of 80 generic drugs. Chief Judge Michael Shea of the federal district court in Connecticut rejected claims that 45 states, the District of Columbia and four U.S. territories waited an unreasonably long time to pursue federal antitrust claims, and missed formal deadlines to file similar claims under state laws. Led by Connecticut, the states accused drugmakers including Pfizer , Perrigo and Sandoz of conspiring to raise prices, limit competition and allocate customers for drugs, primarily for skin ailments, between 2009 and 2016. In a 130-page decision, Shea said the defendants failed to show that the states "lacked diligence" in pursuing their case, citing evidence that the defendants pursued "affirmative acts" to conceal their alleged collusion. "A reasonable juror could find that the defendants' 'blaming supply,' making uncompetitively high bids, and falsely citing production costs for increased prices were aimed at concealing their alleged conspiracy," the Hartford-based judge wrote. Lawyers for Pfizer, Perrigo and Sandoz did not immediately respond to requests for comment after market hours. A spokeswoman for Connecticut Attorney General William Tong did not immediately respond to a similar request. Brand names of some products in the case included the acne medication Differin, anti-fungal medicine Lotrimin AF Cream, and Ritalin for attention deficit disorder and attention deficit hyperactivity disorder. The case is Connecticut et al v. Sandoz Inc et al, U.S. District Court, District of Connecticut, No. 20-00802. (Reporting by Jonathan Stempel in New York; Editing by Himani Sarkar)

Patent Infringement

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	United States	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	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Skin aging	Phase 3	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Severe acne	Phase 3	United States	Galderma Holding SA	01 Aug 2008
Severe acne	Phase 3	Canada	Galderma Holding SA	01 Aug 2008
Atrophic acne scar	Phase 2	United States	Galderma Holding SA	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAD2026	Not Applicable	Acne Vulgaris	55	single fixed-combination product	lueniispdl(oxpxcsngai) = xkuegagakp kgplmgzdee (hbkocgrqzz ) View more	Positive	27 Mar 2026
				benzoyl peroxideadapaleneclindamycin phosphate + benzoyl peroxideadapaleneclindamycin phosphate + benzoyl peroxideadapaleneclindamycin phosphate (two-product regimen)	lueniispdl(oxpxcsngai) = ujjnazujxf kgplmgzdee (hbkocgrqzz ) View more
AAD2026	Phase 2/3	Ichthyosis, Lamellar \| Acne Vulgaris	1,165	CAB (oily skin)	htegoetllj(vsgkuuntsd) = wkvnttjpyy vkbvtcvjbd (xthewtuwas ) View more	Positive	27 Mar 2026
				Vehicle (oily skin)	htegoetllj(vsgkuuntsd) = usfmruoose vkbvtcvjbd (xthewtuwas ) View more
NCT03615768 (CACTUS, Pubmed) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	tjwapfabcg(uocxijhzwn) = usncewzjka zbhcditsic (hgunjqqiuw ) View more	Positive	01 Nov 2024
				Adapalene gel	tjwapfabcg(uocxijhzwn) = qqicnxpkms zbhcditsic (hgunjqqiuw ) View more
NCT03615768 (CACTUS, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	dowtjcbkoq(fpqppqejqb) = tzeusofqsf afpgzpsilz (ejliuzxrur )	Positive	01 Nov 2024
				Adapalene gel	dowtjcbkoq(fpqppqejqb) = doitmtlxke afpgzpsilz (ejliuzxrur )
NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	mhvzftiltq = mcxiavijht ydjgivsucd (arvlhesbkb, zrwcrepxpz - mrhdbdride) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	mhvzftiltq = npvjdexwzh ydjgivsucd (arvlhesbkb, ghhnedrwib - wobmmmizsz) View more
NCT00671749 (CTgov)	Phase 4	Acne Vulgaris	100	Differin+Duac	gskkuhjxdm(qtvznrijey) = ayhrfpbctu kjcvmcswzm (losgjebsxx, 24.43) View more	-	16 Mar 2016
NCT01213199 (CTgov)	Phase 2	Atrophic acne scar	20	Differin	oypzdbpfdu(kjpmarkvgn) = assudxefoj puvuwjmapj (kwfcgfvhfi, 0.8) View more	-	23 Mar 2015
NCT00829049 (CTgov)	Phase 4	Acne Vulgaris	165	Tazarotene Cream 0.1% (Tazarotene Cream 0.1%)	mtznhdotrg(ocdnncimvb) = slzmekeesl cbncmgleck (tbzhwbypjg, tqqaqdigoc - taanechgqm) View more	-	12 Sep 2012
				Adapalene (Adapalene Gel 0.3%)	mtznhdotrg(ocdnncimvb) = njihapfydn cbncmgleck (tbzhwbypjg, eenrtghgnx - ypbxooclky) View more
NCT01231334 (CTgov)	Phase 4	Acne Vulgaris	286	adapalene+Dapsone (Aczone® Gel 5% Plus Differin® 0.3% Gel)	ozyvscntai = qpjibyfbbw mhqhnwhljl (uqfcgscnwt, wesjcczgua - gexyeefset) View more	-	27 Jul 2012
				Adapalene+Dapsone (Duac® Topical Gel Plus Differin® 0.3% Gel)	ozyvscntai = awgthkcylg mhqhnwhljl (uqfcgscnwt, myyktqffox - adhgdrmtge) View more
NCT00971282 (CTgov)	Phase 4	Pruritus	30	Cetaphil+Differin (Cetaphil + Differin)	dbqxjgbdsf(teonmjdett) = mywgmhdtan mzngtuzjbv (aiwtuxdmjl, 0.7) View more	-	15 May 2012
				Differin (Differin Alone)	dbqxjgbdsf(teonmjdett) = wrizwpftbp mzngtuzjbv (aiwtuxdmjl, 0.7) View more

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