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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena®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

Clinical Trial Conditions for Adapalene And Benzoyl Peroxide

Condition Name

Condition Name for Adapalene And Benzoyl Peroxide
Intervention	Trials
Acne Vulgaris	30
Acne	10
Atrophic Acne Scars	1
Microparticles	1

Condition MeSH

Condition MeSH for Adapalene And Benzoyl Peroxide
Intervention	Trials
Acne Vulgaris	39
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	112
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
North Carolina	7
Florida	7
California	7

Clinical Trial Progress for Adapalene And Benzoyl Peroxide

Clinical Trial Phase

Clinical Trial Phase for Adapalene And Benzoyl Peroxide
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	14
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Adapalene And Benzoyl Peroxide
Clinical Trial Phase	Trials
Completed	34
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
Galderma Laboratories, L.P.	6

Sponsor Type

Sponsor Type for Adapalene And Benzoyl Peroxide
Sponsor	Trials
Industry	55
Other	14

Adapalene and Benzoyl Peroxide: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

The combination of adapalene and benzoyl peroxide has emerged as a highly effective treatment for mild to moderate acne, garnering significant attention in both clinical and market realms. This article delves into the clinical trials, market analysis, and future projections for this potent acne treatment.

Clinical Efficacy and Safety

Combination Therapy Benefits

Clinical trials have consistently demonstrated the efficacy and safety of the adapalene 0.1% and benzoyl peroxide 2.5% combination gel. This fixed-dose combination targets multiple aspects of acne pathogenesis, including comedogenesis, hyperkeratinization, inflammation, and the reduction of propionibacteria, without promoting antibiotic resistance[1].

Comparative Studies

Studies have shown that the combination of adapalene and benzoyl peroxide provides significantly greater additive efficacy and a more rapid onset of action compared to monotherapies or vehicle controls. Patients with higher baseline lesion counts benefit the most from this combination, with no increase in adverse events or worse tolerability scores[3].

Long-Term Tolerability

A long-term tolerability and safety study involving 425 patients confirmed the long-term efficacy and safety of this combination gel over 12 months, highlighting its suitability for prolonged use[1].

Market Analysis

Market Size and Growth

The Adapalene Benzoyl Peroxide Gel Market was valued at USD 3.04 billion in 2023 and is projected to reach USD 6.01 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.96% from 2024 to 2031. This growth is driven by the increasing demand for effective acne treatments, particularly among teenagers and young adults[2].

Market Segmentation

The market is segmented based on type and application, with online and offline sales being key categories. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa, with emerging markets showing significant potential for growth[2].

Consumer and Dermatologist Preference

The combination gel is gaining popularity among both consumers and dermatologists due to its proven efficacy, convenience, and favorable safety profile. The rising awareness of skincare and self-care, coupled with the availability of over-the-counter formulations, has further boosted its demand[5].

Market Trends and Drivers

Increasing Prevalence of Acne

The growing prevalence of acne, especially among adolescents and young adults, is a major driver of the market. It is estimated that nearly 85% of individuals aged 12 to 24 experience some form of acne, creating a vast market for effective treatments[5].

Advancements in Dermatological Research

Continuous advancements in dermatological research and the development of new product formulations are expected to drive market growth. The integration of digital health platforms and e-commerce has also transformed the way skincare products are purchased, expanding the customer base globally[5].

Investment Opportunities

There are significant investment opportunities in manufacturing and distribution, emerging markets, and digital health and e-commerce. Companies involved in the production and distribution of acne treatments are well-positioned to benefit from the growing demand, while emerging markets offer a fertile ground for expansion[5].

Comparison with Other Treatments

Triple-Combination Therapy

While the adapalene and benzoyl peroxide combination is highly effective, there is also interest in triple-combination therapies that include clindamycin, adapalene, and benzoyl peroxide. These therapies have shown even higher efficacy rates and favorable tolerability profiles, although they are not yet as widely available as the dual-combination gel[4].

Efficacy and Tolerability

The triple-combination therapy has demonstrated a 30% delta in success rates compared to vehicle controls, significantly higher than most single-ingredient or dual-ingredient topical therapies. However, the discontinuation rates due to adverse effects for both the dual and triple combinations are relatively low, indicating good tolerability[4].

Patient Adherence

Fixed-Dose Combination Benefits

Fixed-dose combination products like the adapalene and benzoyl peroxide gel have been shown to improve patient adherence. Studies indicate that patients are more likely to adhere to fixed-dose combination products compared to using individual components separately, leading to better outcomes in acne management[4].

Key Takeaways

• The adapalene 0.1% and benzoyl peroxide 2.5% combination gel is a highly effective treatment for mild to moderate acne, offering rapid onset and long-term efficacy.
• The market for this combination gel is projected to grow significantly, driven by increasing demand for effective acne treatments and advancements in dermatological research.
• Emerging markets and digital health platforms present substantial opportunities for growth and investment.
• Fixed-dose combination products enhance patient adherence, leading to better treatment outcomes.

FAQs

What are the key ingredients in the adapalene and benzoyl peroxide combination gel?

The key ingredients are adapalene 0.1% and benzoyl peroxide 2.5%.

How effective is the adapalene and benzoyl peroxide combination compared to monotherapies?

The combination provides significantly greater additive efficacy and a more rapid onset of action compared to monotherapies or vehicle controls[1].

What is the projected market size for the adapalene benzoyl peroxide gel by 2031?

The market is expected to reach USD 6.01 billion by 2031, growing at a CAGR of 8.96% from 2024 to 2031[2].

What are the main drivers of the market growth for this combination gel?

The main drivers include the increasing prevalence of acne, advancements in dermatological research, and the growing awareness of skincare and self-care[5].

How does the adapalene and benzoyl peroxide combination impact patient adherence?

Fixed-dose combination products like this gel improve patient adherence by simplifying treatment regimens and enhancing compliance[4].

Sources

1. Benzoyl peroxide and adapalene fixed combination: a novel agent ... - Academic.oup.com
2. Adapalene Benzoyl Peroxide Gel Market Size and Projections - MarketResearchIntellect.com
3. The efficacy of adapalene-benzoyl peroxide combination increases ... - PubMed.ncbi.nlm.nih.gov
4. Exploring a Triple-Combination Therapy for Acne Management - Dermsquared.com
5. The Rapid Growth of the Adapalene Benzoyl Peroxide Gel Market - MarketResearchIntellect.com