CLINICAL TRIALS PROFILE FOR ADAPALENE

505(b)(2) Clinical Trials for adapalene

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Lee's Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
OTC	NCT03650881 ↗	The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.
OTC	NCT03650881 ↗	The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.

All Clinical Trials for adapalene

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00421993 ↗	A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris	Completed	Galderma	Phase 3	2006-10-01	This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
NCT00237978 ↗	Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)	Unknown status	Technische Universität Dresden	Phase 4	2006-09-01	The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.
NCT00151541 ↗	A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%	Completed	Allergan	Phase 3	2005-02-01	The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 ↗	Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris	Completed	Stiefel, a GSK Company	Phase 4	2004-12-01	Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.

Clinical Trial Conditions for adapalene

Condition Name

Condition Name for adapalene
Intervention	Trials
Acne Vulgaris	59
Acne	12
Photoaging	2
Skin Manifestations	2

Condition MeSH

Condition MeSH for adapalene
Intervention	Trials
Acne Vulgaris	72
Atrophy	2
Skin Manifestations	2
Keratosis, Actinic	1

Clinical Trial Locations for adapalene

Trials by Country

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Trials by Country for adapalene
Location	Trials
United States	224
Canada	30
Brazil	12
India	7
Germany	5

Trials by US State

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−

Trials by US State for adapalene
Location	Trials
Texas	21
North Carolina	15
California	15
Florida	13
Pennsylvania	11

Clinical Trial Progress for adapalene

Clinical Trial Phase

Clinical Trial Phase for adapalene
Clinical Trial Phase	Trials
Phase 4	34
Phase 3	22
Phase 2	7

Clinical Trial Status

Clinical Trial Status for adapalene
Clinical Trial Phase	Trials
Completed	61
Unknown status	5
Recruiting	4

Clinical Trial Sponsors for adapalene

Sponsor Name

Sponsor Name for adapalene
Sponsor	Trials
Galderma	17
Galderma R&D	17
Galderma Laboratories, L.P.	11

Sponsor Type

Sponsor Type for adapalene
Sponsor	Trials
Industry	91
Other	32

Adapalene: Clinical Trials, Market Analysis, and Projections

Introduction to Adapalene

Adapalene, a naphthoic-acid derivative, is a topical retinoid widely used in the treatment of acne vulgaris and other dermatological conditions. Its unique properties make it an effective and well-tolerated option for patients.

Clinical Trials and Efficacy

Maintenance Therapy with Adapalene

A significant clinical trial demonstrated the efficacy of adapalene gel 0.1% as a maintenance therapy for acne vulgaris. In this study, subjects who had shown at least a 50% improvement from baseline after a 12-week treatment with either adapalene plus doxycycline or doxycycline plus gel vehicle were randomized to receive adapalene gel 0.1% or gel vehicle for an additional 16 weeks. The results showed that adapalene maintained superior efficacy compared to the vehicle, with significantly lower total, inflammatory, and noninflammatory lesion counts at the end of the 16-week period[1].

Comparison with Tretinoin

Several pivotal clinical trials have compared the efficacy and tolerability of adapalene with tretinoin, another common topical retinoid. These studies have consistently shown that adapalene gel 0.1% and solution 0.1% are at least as effective as tretinoin gel 0.025%, with superior local tolerability. Adapalene cream 0.1% also demonstrated significant efficacy over vehicle, with response rates comparable to those of the gel and solution formulations. The superior tolerability and rapid onset of clinical effect make adapalene a valuable addition to acne treatments[3].

Adapalene-Clindamycin Combination Gel

A recent Phase III clinical trial evaluated the efficacy of an adapalene 0.1%-clindamycin 1% combination gel compared to adapalene gel 0.1% and clindamycin gel 1% monotherapies. The results indicated that the combination gel was well-tolerated and demonstrated superior efficacy, with a significant reduction in total lesion count and a higher percentage of patients achieving at least a 2-grade improvement in the Investigator's Global Assessment (IGA) at week 12[4].

Market Analysis

Market Size and Growth

The adapalene drugs market is driven by several key factors, including the growing prevalence of acne, increasing awareness about skincare, and advancements in drug formulations. The market is expected to grow significantly over the next few years, with projections indicating a robust expansion in the global adapalene market from 2025 to 2030[2].

Market Segmentation

The adapalene market is segmented by product type (cream, gel, lotion), application (acne vulgaris, dark spots, psoriasis), distribution channel, patient demographics, and end-user. The gel formulation remains one of the most popular due to its efficacy and tolerability. The market also sees potential in targeting aging populations for anti-aging effects and in expanding product lines to include various formulations[2][5].

Key Market Players

Major companies contributing to the growth of the adapalene market include Galderma Laboratories, L.P., Allergan plc, Bausch Health Companies Inc., Perrigo Company plc, and several others. These companies are adopting various strategies such as collaborations, new product innovations, and technological advancements to stay competitive in the market[5].

Market Drivers

• Growing Prevalence of Acne: The increasing incidence of acne among teenagers and young adults is a significant driver of the market.
• Expanding Dermatology Services: The growth in dermatology clinics and professional skincare services amplifies prescriptions for adapalene products.
• E-commerce Platforms: The widespread distribution and visibility of adapalene products through e-commerce platforms have boosted market demand[2].

Market Restraints

• Supply Chain Disruptions: Overcoming supply chain disruptions affecting the availability of key components for adapalene drugs is a significant challenge.
• Building Healthcare Provider Trust: Addressing criticisms and building trust among healthcare providers in prescribing adapalene drugs is crucial for market growth[2].

Market Projections

Future Growth Opportunities

The adapalene market is poised for significant growth, driven by several opportunities:

• Targeting Aging Populations: Adapalene products focusing on wrinkle and fine line reduction are expected to gain traction.
• E-commerce Expansion: Direct sales to consumers through e-commerce platforms offer substantial growth potential.
• Increasing Skincare Awareness: Growing consumer awareness about skincare, especially in urban populations, is expected to drive demand[2][5].

Geographical Expansion

The market is expected to expand in emerging markets where skincare awareness is increasing. Strategic partnerships with dermatologists and enhanced digital marketing efforts are recommended to capitalize on these opportunities[2].

Consumer Satisfaction and Tolerability

Clinical trials have consistently shown that adapalene is well-tolerated and highly effective. In one study, a significant percentage of subjects receiving adapalene maintenance therapy were "very satisfied" or "satisfied" with the treatment effectiveness and overall maintenance treatment, compared to those receiving the vehicle[1].

Key Takeaways

• Efficacy in Clinical Trials: Adapalene has demonstrated superior efficacy in maintaining acne treatment outcomes and in combination with clindamycin.
• Market Growth Drivers: Growing acne prevalence, expanding dermatology services, and e-commerce platforms are key drivers.
• Market Restraints: Supply chain disruptions and building healthcare provider trust are significant challenges.
• Future Opportunities: Targeting aging populations, e-commerce expansion, and increasing skincare awareness are potential growth areas.
• Consumer Satisfaction: Adapalene is well-tolerated and highly effective, leading to high consumer satisfaction.

FAQs

What is adapalene and how is it used?

Adapalene is a topical retinoid used primarily for the treatment of acne vulgaris. It is available in various formulations such as gel, cream, and lotion.

What are the key findings from clinical trials on adapalene?

Clinical trials have shown that adapalene is effective in maintaining acne treatment outcomes, has superior local tolerability compared to tretinoin, and is highly effective when combined with clindamycin.

What are the main drivers of the adapalene market?

The main drivers include the growing prevalence of acne, expanding dermatology services, and the growth of e-commerce platforms.

What challenges does the adapalene market face?

The market faces challenges such as supply chain disruptions and the need to build trust among healthcare providers.

What are the future growth opportunities for the adapalene market?

Future growth opportunities include targeting aging populations for anti-aging effects, expanding through e-commerce platforms, and increasing penetration in emerging markets.

Sources

1. JAMA Dermatology: "Adapalene Gel, 0.1%, as Maintenance Therapy for Acne Vulgaris"[1]
2. 360iResearch: "Adapalene Drugs Market Size & Share 2025-2030"[2]
3. PubMed: "Pivotal clinical trials of adapalene in the treatment of acne"[3]
4. PubMed: "A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial"[4]
5. OpenPR: "Global Adapalene Market Outlook Opportunities and Innovations Till 2032"[5]