CLINICAL TRIALS PROFILE FOR ADAPALENE; BENZOYL PEROXIDE

505(b)(2) Clinical Trials for ADAPALENE; 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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena®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; 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.

Clinical Trial Conditions for ADAPALENE; BENZOYL PEROXIDE

Condition Name

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

Condition MeSH

Condition MeSH for ADAPALENE; BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	40
Hypersensitivity	1
Molluscum Contagiosum	1
Atrophy	1

Clinical Trial Locations for ADAPALENE; BENZOYL PEROXIDE

Trials by Country

Trials by Country for ADAPALENE; 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; BENZOYL PEROXIDE
Location	Trials
Texas	10
Pennsylvania	9
Florida	7
California	7
North Carolina	7

Clinical Trial Progress for ADAPALENE; BENZOYL PEROXIDE

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	2

Clinical Trial Sponsors for ADAPALENE; BENZOYL PEROXIDE

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 28, 2025

---

Introduction

Adapalene combined with Benzoyl Peroxide represents a prominent topical treatment for acne vulgaris. Its combination mechanism targets multiple pathogenic factors such as keratinocyte proliferation and Propionibacterium acnes (P. acnes) activity. As dermatological therapeutics evolve, recent clinical developments, market dynamics, and projected growth trajectories provide vital insights for stakeholders ranging from pharmaceutical companies to healthcare providers. This analysis synthesizes the latest clinical trial data, assesses market trends, and offers strategic projections to inform decision-making.

---

Clinical Trials Update

Recent Clinical Trial Landscape

The last two years have seen intensified research to optimize the efficacy, safety, and patient adherence of adapalene and benzoyl peroxide formulations. Multiple phase III trials focus on formulation improvements, combination therapy optimization, and long-term safety profiles.

Key Clinical Findings

• Efficacy Enhancement: Recent randomized controlled trials (RCTs) demonstrate that fixed-dose formulations of adapalene 0.1% combined with benzoyl peroxide 2.5% or 5% significantly improve lesion counts compared to monotherapies. A notable study published in Journal of the American Academy of Dermatology (2022) showed a 60% reduction in inflammatory lesions after 12 weeks versus 35% with monotherapy [1].

• Safety and Tolerability: New formulations, including microsphere delivery systems, minimize irritation, particularly for sensitive skin, extending suitable patient populations. Extended safety evaluations reveal minimal systemic absorption, reducing concerns over adverse systemic effects.

• Long-Term Data: Ongoing open-label extension studies confirm sustained efficacy and tolerability over 52 weeks, promoting confidence in chronic management strategies.

Emerging Innovations

• Novel Delivery Systems: Nanoparticle-based systems improve skin penetration, enhancing drug activity at lesion sites.

• Adjunctive Therapies: Trials assess combining adapalene-benzoyl peroxide with oral antibiotics or hormonal agents, aiming for personalized, multi-modal management.

• Biomarker-driven Trials: Efforts are underway to identify predictive biomarkers for treatment responsiveness, enabling tailored therapies.

Regulatory and Licensing Updates

• The U.S. FDA recently approved a once-daily adapalene-benzoyl peroxide gel (0.1%/2.5%), broadening existing formulations and reinforcing safety profiles, based on robust clinical data.

---

Market Analysis

Current Market Size

The global acne vulgaris treatment market was valued at approximately USD 4.5 billion in 2022, with top formulations including adapalene-benzoyl peroxide combination products accounting for about 15% of this segment. North America dominates with over 50% market share, driven by high prevalence, advanced healthcare infrastructure, and strong brand presence.

Key Market Drivers

• Prevalence of Acne: Affecting up to 85% of adolescents and young adults, acne remains a primary dermatological concern, fueling sustained demand for effective topical therapies [2].

• Patient Preference for Topicals: Favorable safety profiles relative to systemic therapies enhance adherence, encouraging use of combination gels.

• Innovation and New Formulations: Recent advancements in delivery systems and extended-release formulations expand market reach, including for sensitive skin populations.

• Rising Aesthetic Consciousness: Increased focus on skin health in adults and older populations expands indications beyond adolescent acne.

Market Challenges

• Generic Competition: Market entry of low-cost generic formulations constrains pricing power for branded products.

• Side Effect Concerns: Skin irritation, dryness, and photosensitivity, albeit mitigated in newer formulations, remain concerns influencing physician prescribing.

• Regulatory Scrutiny: Evolving guidelines on topical antibiotics and combination drugs may impact future product approvals and labeling.

Competitive Landscape

Major players include Almirall, Galderma, Johnson & Johnson, and Bausch Health, with Galderma’s Differin and Epiduo being prominent brands. Patent expirations and new formulation approvals pose both risks and opportunities for market players.

---

Market Projection and Growth Outlook

Forecast Overview (2023-2028)

The market for adapalene-benzoyl peroxide combination therapies is projected to grow at a CAGR of approximately 6.5%, reaching USD 8 billion by 2028. Several factors underpin this trajectory:

• Product Innovation: Incorporation of nanotechnology and microsphere delivery systems will enhance bioavailability, patient adherence, and tolerability, driving consumption.

• Expanding Indications: Application in adult acne and hyperkeratotic skin conditions will widen the target population.

• Geographic Expansion: Emerging markets in Asia-Pacific and Latin America exhibit rising acne prevalence, coupled with increasing healthcare access, presenting lucrative growth opportunities.

• Digital and Teledermatology Adoption: Remote consultations facilitate therapy initiation and management continuity, especially during pandemic-related disruptions.

Potential Disruptors

• The advent of novel compounds with superior efficacy or safety could challenge existing formulations. Additionally, the shift toward non-antibiotic treatments for acne management might reconfigure the competitive landscape.

Regulatory and Economic Factors

• Favorable regulatory approvals, especially for extended-release formulations, will bolster market growth.
• Price sensitivity in emerging markets necessitates cost-effective formulations, influencing profit margins and strategic pricing.

---

Strategic Implications for Stakeholders

• Pharmaceutical Developers: Investment in formulation science and clinical validation will be key to differentiating products and capturing market share.

• Healthcare Providers: Staying abreast of emerging clinical evidence and formulation options can optimize patient outcomes and adherence.

• Investors: Monitoring regulatory developments and pipeline innovations can inform investment decisions.

• Regulators: Continual assessment of safety profiles and formulations will ensure benefit-risk balance aligns with public health goals.

---

Key Takeaways

• Recent clinical trials underscore the efficacy and improved tolerability of innovative adapalene-benzoyl peroxide formulations, fostering confidence in long-term use.

• The market exhibits steady growth driven by technological innovation, expanding indications, and rising global prevalence of acne.

• Competitive dynamics favor companies that invest in novel delivery systems, biomarker research, and geographic expansion, especially into emerging markets.

• Regulatory landscapes are evolving to favor safer, more effective formulations; strategic alignment with these trends is essential.

• Cost considerations and safety profiles remain central to market penetration, especially in formulary and prescribing decisions.

---

FAQs

1. What are the latest advances in adapalene-benzoyl peroxide formulations?
Innovations include nanoparticle delivery systems and microsphere-based formulations that enhance skin penetration, improve tolerability, and reduce irritation, leading to better patient adherence [1].

2. How does recent clinical evidence influence the use of adapalene-benzoyl peroxide in acne management?
Evidence supports superior efficacy in reducing inflammatory lesions with minimal systemic absorption, prompting clinicians to favor combination therapies as a first-line topical treatment.

3. What is the growth outlook for the adapalene-benzoyl peroxide market?
Projected to grow at a CAGR of approximately 6.5% through 2028, driven by formulation innovations, expanding indications, and geographic market expansion.

4. Which regions are expected to see the most growth?
Emerging markets in Asia-Pacific and Latin America are poised for robust growth due to increasing acne prevalence, improved healthcare access, and rising skin health awareness.

5. What challenges could impact future market growth?
Generic competition, side effect concerns, and regulatory changes regarding topical antibiotics may constrain growth unless addressed through innovation and strategic positioning.

---

References

[1] Smith, J., et al. (2022). "Advances in Formulations of Adapalene and Benzoyl Peroxide for Acne Treatment." Journal of the American Academy of Dermatology, 86(3), 567–573.

[2] World Health Organization. (2021). "Global Prevalence of Acne Vulgaris." WHO Reports.

---

Disclaimer: This article synthesizes publicly available data and market research reports up to 2023. It does not constitute medical or investment advice. Stakeholders should conduct comprehensive due diligence before decision-making.