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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena®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

Condition Name

Condition Name for ADAPALENE; BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	30
Acne	10
Atrophic Acne Scars	1
Microparticles	1

Condition MeSH

Condition MeSH for ADAPALENE; BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	39
Molluscum Contagiosum	1
Atrophy	1
Hyperpigmentation	1

Clinical Trial Locations for ADAPALENE; BENZOYL PEROXIDE

Trials by Country

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−

Trials by Country for ADAPALENE; BENZOYL PEROXIDE
Location	Trials
United States	112
Canada	18
Brazil	7
India	5
Poland	4

Trials by US State

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−

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

Clinical Trial Progress for ADAPALENE; BENZOYL PEROXIDE

Clinical Trial Phase

Clinical Trial Phase for ADAPALENE; BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	14
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ADAPALENE; BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	34
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
Galderma Laboratories, L.P.	6

Sponsor Type

Sponsor Type for ADAPALENE; BENZOYL PEROXIDE
Sponsor	Trials
Industry	55
Other	14

Adapalene and Benzoyl Peroxide: Clinical Trials, Market Analysis, and Projections

Introduction to Adapalene and Benzoyl Peroxide

Adapalene and benzoyl peroxide are two well-established ingredients in the treatment of acne vulgaris. When combined in a fixed-dose gel, they offer a potent and effective solution for managing mild to moderate acne. Here, we will delve into the clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials and Efficacy

Trial Overview

Clinical trials have consistently shown the efficacy of the adapalene and benzoyl peroxide fixed-dose combination gel. A notable study published in the Journal of the American Academy of Dermatology involved 517 subjects randomized to receive either the adapalene-BPO gel, adapalene, BPO, or a vehicle for 12 weeks. The results indicated that the fixed-dose combination gel was significantly more effective than the corresponding monotherapies, with significant differences in total lesion counts observed as early as one week[1].

Safety and Tolerability

The safety profile of the adapalene-BPO gel was found to be comparable to that of adapalene monotherapy. The frequency of adverse events and the cutaneous tolerability profile were similar, indicating that the combination does not significantly increase the risk of adverse effects[1].

Pediatric Use

Trials have also been conducted to evaluate the efficacy and safety of adapalene-BPO gel in younger populations. For instance, a trial demonstrated the efficacy of the gel in children aged 9 to 11 years, with no safety signals detected in this age group[4].

Market Analysis

Current Market Size

The Adapalene Benzoyl Peroxide Gel Market was valued at USD 3.04 billion in 2023. This market is segmented based on type, application, and geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[2].

Growth Projections

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 8.96% from 2024 to 2031, reaching USD 6.01 billion by 2031. This growth is driven by the increasing demand for effective acne treatments, particularly among teenagers and young adults[2].

Key Drivers

• Increasing Prevalence of Acne: The rising incidence of acne, especially among adolescents and young adults, is a significant driver. It is estimated that nearly 85% of individuals aged 12 to 24 experience some form of acne[5].
• Growing Awareness of Skincare: The increasing awareness about skincare and self-care has led to a higher demand for over-the-counter acne treatments like the adapalene-BPO gel[5].
• Advancements in Dermatological Research: Continuous research and development in dermatology, including new product formulations, are expected to drive market growth[2].

Market Segments and Opportunities

Type and Application Segments

The market is categorized into different types (Type I, Type II, Type III, Type IV) and applications (Online Sales, Offline Sales). The segmentation helps in understanding the diverse needs of consumers and the strategies required to cater to these segments[2].

Emerging Markets

Emerging markets, particularly in Asia-Pacific, Latin America, and Africa, present significant growth opportunities. These regions are experiencing rising incomes and greater interest in dermatological treatments, creating a fertile environment for the growth of the adapalene-BPO gel market[5].

Digital Health and E-commerce

The growth of digital health platforms and e-commerce has transformed the way skincare products are purchased. Companies leveraging online sales channels can expand their customer base and ensure global accessibility of their products[5].

Regulatory Approvals

FDA Approvals

The U.S. Food and Drug Administration (FDA) has approved several formulations of adapalene and benzoyl peroxide gel. For example, in June 2022, Zydus Lifesciences received FDA approval for the marketing of Adapalene and Benzoyl Peroxide topical gel in the U.S.[3].

Consumer Behavior and Preferences

Self-Care and Over-the-Counter Options

The rise of self-care and the availability of over-the-counter options have made the adapalene-BPO gel a popular choice among consumers. Its accessibility and effectiveness have contributed significantly to its market growth[5].

Cost-Effectiveness

The gel is positioned as a cost-effective option for consumers, which has further boosted its demand. As more people opt for affordable and effective acne treatments, the market for this gel is expected to continue growing[5].

Key Players and Market Dynamics

Established and Emerging Players

The market report includes extensive lists of prominent companies categorized by the types of products they offer. Companies involved in the production and distribution of acne treatments are well-positioned to benefit from the growing demand for adapalene-BPO gel[2].

Market Trends and Factors

The report employs both quantitative and qualitative analyses to project trends across the timeframe from 2023 to 2031. It considers product pricing, market dynamics, consumer behavior, and the economic, political, and social landscapes of various countries[2].

Conclusion

The combination of adapalene and benzoyl peroxide in a fixed-dose gel has proven to be a highly effective treatment for mild to moderate acne. Clinical trials have demonstrated its efficacy and safety, while market analysis indicates a strong growth trajectory driven by increasing demand and advancements in dermatological research.

Key Takeaways

• Efficacy and Safety: The adapalene-BPO gel is significantly more effective than monotherapies and has a comparable safety profile to adapalene monotherapy.
• Market Growth: The market is expected to grow from USD 3.04 billion in 2023 to USD 6.01 billion by 2031, driven by increasing demand and growing awareness of skincare.
• Emerging Markets: Regions like Asia-Pacific, Latin America, and Africa offer significant growth opportunities due to rising incomes and greater interest in dermatological treatments.
• Digital Health and E-commerce: Online sales channels are crucial for expanding the customer base and ensuring global accessibility of the product.
• Regulatory Approvals: FDA approvals for various formulations have supported the market growth of the adapalene-BPO gel.

FAQs

What is the current market size of the Adapalene Benzoyl Peroxide Gel Market?

The Adapalene Benzoyl Peroxide Gel Market was valued at USD 3.04 billion in 2023[2].

What is the projected growth rate of the Adapalene Benzoyl Peroxide Gel Market?

The market is expected to grow at a CAGR of 8.96% from 2024 to 2031[2].

What are the key drivers of the Adapalene Benzoyl Peroxide Gel Market?

Key drivers include the increasing prevalence of acne, growing awareness of skincare, and advancements in dermatological research[2][5].

Which regions offer significant growth opportunities for the Adapalene Benzoyl Peroxide Gel Market?

Emerging markets in Asia-Pacific, Latin America, and Africa offer significant growth opportunities due to rising incomes and greater interest in dermatological treatments[5].

What role does digital health and e-commerce play in the growth of the Adapalene Benzoyl Peroxide Gel Market?

Digital health platforms and e-commerce have transformed the way skincare products are purchased, allowing companies to expand their customer base and ensure global accessibility of their products[5].

Sources

1. Journal of the American Academy of Dermatology: "Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne."
2. Market Research Intellect: "Adapalene Benzoyl Peroxide Gel Market Size and Projections."
3. Fortune Business Insights: "Acne Treatment Market Size, Trends | Revenue Share [2032]."
4. FDA: "22320 Adapalene benzoyl Clinical PREA."
5. Market Research Intellect: "Clearer Skin Ahead: The Rapid Growth of the Adapalene Benzoyl Peroxide Gel Market."