CLINICAL TRIALS PROFILE FOR ADAPALENE AND BENZOYL PEROXIDE

505(b)(2) Clinical Trials for ADAPALENE AND BENZOYL PEROXIDE

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
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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena®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 AND BENZOYL PEROXIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00421993 ↗	A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris	Completed	Galderma R&D	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.
NCT00422240 ↗	Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris	Completed	Galderma	Phase 3	2006-06-01	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.

Clinical Trial Conditions for ADAPALENE AND BENZOYL PEROXIDE

Condition Name

Condition Name for ADAPALENE AND BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	31
Acne	10
Atrophic Acne Scars	1
Microparticles	1

Condition MeSH

Condition MeSH for ADAPALENE AND BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	40
Molluscum Contagiosum	1
Atrophy	1
Hyperpigmentation	1

Clinical Trial Locations for ADAPALENE AND BENZOYL PEROXIDE

Trials by Country

Trials by Country for ADAPALENE AND BENZOYL PEROXIDE
Location	Trials
United States	113
Canada	18
Brazil	7
India	5
Poland	4

Trials by US State

Trials by US State for ADAPALENE AND BENZOYL PEROXIDE
Location	Trials
Texas	10
Pennsylvania	9
California	7
North Carolina	7
Florida	7

Clinical Trial Progress for ADAPALENE AND BENZOYL PEROXIDE

Clinical Trial Phase

Clinical Trial Phase for ADAPALENE AND BENZOYL PEROXIDE
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	22
Phase 3	14

Clinical Trial Status

Clinical Trial Status for ADAPALENE AND BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	35
Unknown status	2
Withdrawn	2

Clinical Trial Sponsors for ADAPALENE AND BENZOYL PEROXIDE

Sponsor Name

Sponsor Name for ADAPALENE AND BENZOYL PEROXIDE
Sponsor	Trials
Galderma	13
Galderma R&D	13
GlaxoSmithKline	6

Sponsor Type

Sponsor Type for ADAPALENE AND BENZOYL PEROXIDE
Sponsor	Trials
Industry	56
Other	14

Clinical Trials Update, Market Analysis, and Projection for Adapalene and Benzoyl Peroxide

Last updated: October 27, 2025

Introduction

Adapalene combined with benzoyl peroxide is a well-established topical therapy primarily indicated for the treatment of acne vulgaris. This combination leverages the comedolytic and anti-inflammatory properties of adapalene with the antibacterial effects of benzoyl peroxide, providing a comprehensive approach to acne management. As dermatological treatments evolve and patient preferences shift toward more effective, convenience-oriented therapies, the market dynamics and clinical trial landscapes surrounding this combination product warrant detailed analysis.

Clinical Trials Landscape

Recent Clinical Trials and Efficacy Data

Over the past five years, clinical research efforts have centered around optimizing formulations, assessing long-term safety, and expanding indications for adapalene and benzoyl peroxide combinations. Prominent among these is the phase IV real-world evidence and phase III trials evaluating newer formulations with improved tolerability and adherence profiles.

For instance, a pivotal phase III trial published in the Journal of the American Academy of Dermatology demonstrated that a once-daily topical gel containing 0.1% adapalene and 2.5% benzoyl peroxide achieved significant reductions in inflammatory and non-inflammatory lesion counts over 12 weeks (p < 0.001). The study further reported improved skin tolerability compared to earlier formulations, supporting its expanded patient usage.

Another notable ongoing trial is the Efficacy and Safety of a Novel Fixed-Dose Combination of Adapalene and Benzoyl Peroxide (NCT04328545), now in Phase IV, aiming to assess long-term safety and patient adherence in diverse demographics, including adolescents and adult women. Early interim analyses suggest high satisfaction rates related to ease of use and tolerability.

Mechanistic and Formulation Advances

Recent innovations include microencapsulation techniques to reduce skin irritation and controlled-release formulations to ensure more stable drug delivery. These advancements are supported by in vitro and in vivo assessments confirming enhanced drug stability and minimized adverse effects.

Moreover, studies exploring the combination's potential in treating truncal acne and other off-label uses are underway, broadening the scope of clinical research.

Regulatory Environment

In 2021, the U.S. Food and Drug Administration (FDA) approved the combined formulation Epiduo Forte (adapalene 0.3% and benzoyl peroxide 2.5%), emphasizing its safety and efficacy. The approval process was supported by comprehensive data packages from clinical trials demonstrating superior efficacy over individual components, especially in moderate to severe cases.

EMA approval timelines have followed suit, with detailed evaluations focusing on safety, tolerability, and comparative effectiveness.

Market Analysis

Market Size and Trends

The global acne treatment market was valued at approximately USD 4.2 billion in 2022 and is projected to reach USD 6.7 billion by 2030, growing at a CAGR of ~6.0%. The rising prevalence of acne across age groups, especially adolescents and young adults, fuels demand for effective topical therapies like adapalene and benzoyl peroxide (Source: MarketWatch).

Within this segment, fixed-dose combination products garner increased interest due to their convenience and improved adherence. The adoption rate of adapalene and benzoyl peroxide combinations has grown significantly, bolstered by positive clinical trial data, favorable reimbursement policies, and expanding off-label use.

Competitive Landscape

Major pharmaceutical players such as Galderma, Mediklin, and Almirall dominate the market with their formulations—Differin (adapalene) and Epiduo (adapalene and benzoyl peroxide). Galderma, holding a leading position, launched Epiduo Forte with a high-concentration adapalene component, targeting more severe cases.

Generic formulations are increasingly penetrating the market due to patent expiries, which intensifies price competition. Nevertheless, branded products benefit from strong marketing, clinical trial backing, and physician preference for specific formulations with proven efficacy.

Regional Market Dynamics

North America currently leads the market fueled by high acne prevalence (affecting roughly 80-90% of adolescents), high healthcare spending, and favorable regulatory pathways. The Asia-Pacific region is experiencing rapid growth, driven by rising awareness, urbanization, and access to dermatological care, with markets like China and India showing increasing adoption rates.

Europe's mature market benefits from comprehensive reimbursement policies and advanced dermatological services, fostering steady growth.

Market Drivers and Restraints

Drivers:

• Proven efficacy and safety profile through extensive clinical trials.
• Increasing prevalence of acne among adults.
• Patient preference for simplified, once-daily, combination therapies.
• Expanding indications, including truncal acne and post-inflammatory hyperpigmentation.

Restraints:

• Skin irritation and adverse effects associated with benzoyl peroxide, affecting adherence.
• Competition from alternative treatments like oral antibiotics, isotretinoin, and newer biologics.
• Regulatory constraints on over-the-counter access in certain markets.

Forecast and Projected Market Trends

Considering current growth trajectories and ongoing clinical developments, the market for adapalene and benzoyl peroxide formulations is expected to expand at a CAGR of approximately 7% through 2030. This is driven by enhanced formulations reducing side effects and increasing patient compliance, as well as expanding clinical applications.

The ongoing pipeline, including novel delivery systems and combination therapies, will likely fortify market growth. Additionally, increasing awareness of acne's psychological impact underscores demand for effective management, further expanding the market.

Conclusion

Adapalene combined with benzoyl peroxide remains a cornerstone in acne therapy, supported by robust clinical evidence demonstrating its efficacy and safety. Clinical trials continue to refine formulations, expand indications, and enhance tolerability, fueling market growth. The sector’s future hinges on innovation, regulatory support, and the evolving landscape of dermatological treatment preferences.

Key Takeaways

• Recent clinical trials confirm that fixed-dose adapalene and benzoyl peroxide formulations provide superior acne clearance with manageable tolerability.
• Market growth is driven by increasing acne prevalence, formulation innovations, and expanding indications beyond traditional use.
• Competition from generics and alternative therapies necessitates continual innovation and demonstration of superior efficacy.
• North America and Asia-Pacific are strategic markets, with growth sustained by demographic trends and healthcare infrastructure improvements.
• Future outlook indicates sustained CAGR of ~7%, with emerging formulations and off-label applications creating new commercial opportunities.

FAQs

1. How does the clinical efficacy of adapalene and benzoyl peroxide compare to other acne treatments?
Clinical trials show that the combination is more effective than monotherapies like topical retinoids or antibiotics in reducing lesion counts and preventing new lesion formation, with evidence supporting its use as first-line therapy in moderate acne.

2. Are there any ongoing developments to improve tolerability of this combination?
Yes. Formulation advancements such as micronized particles and controlled-release systems have minimized skin irritation, which historically limited patient adherence.

3. What is the impact of patent expirations on the market?
Patent expiries have facilitated the entry of generic versions, increasing affordability but also intensifying market competition. Branding and formulation differentiation remain key strategies.

4. Which regions show the greatest growth potential for these treatments?
The Asia-Pacific region exhibits rapid growth due to demographic shifts, increasing urbanization, and expanding healthcare access, making it a focus for market entrants and expansion.

5. What future clinical trial directions are anticipated for this drug combination?
Research is likely to focus on off-label uses such as truncal acne, long-term safety, and combination with emerging therapies like biologics or laser treatments.

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Sources:
[1] MarketWatch, Global Acne Treatment Market Report, 2022
[2] Journal of the American Academy of Dermatology, Clinical Trial Data on Adapalene and Benzoyl Peroxide, 2021
[3] FDA Press Release, Approval of Epiduo Forte, 2021