CLINICAL TRIALS PROFILE FOR BENZOYL PEROXIDE

505(b)(2) Clinical Trials for 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
New Dosage	NCT02058628 ↗	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2014-02-21	This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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.
OTC	NCT04021524 ↗	BPO vs Hibiclens Soap for Surgical Preparation	Unknown status	University of Washington	Phase 4	2018-09-10	This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).

All Clinical Trials for 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.
NCT00377000 ↗	A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.	Completed	Sanofi	Phase 4	2005-11-01	Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.

Clinical Trial Conditions for BENZOYL PEROXIDE

Condition Name

Condition Name for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	79
Acne	14
Foot Dermatoses	3
Surgical Site Infection	2

Condition MeSH

Condition MeSH for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	94
Skin Diseases	4
Foot Dermatoses	3
Infections	3

Clinical Trial Locations for BENZOYL PEROXIDE

Trials by Country

Trials by Country for BENZOYL PEROXIDE
Location	Trials
United States	245
Canada	23
India	15
Germany	14
China	9

Trials by US State

Trials by US State for BENZOYL PEROXIDE
Location	Trials
California	19
Texas	18
Florida	16
Pennsylvania	16
North Carolina	15

Clinical Trial Progress for BENZOYL PEROXIDE

Clinical Trial Phase

Clinical Trial Phase for BENZOYL PEROXIDE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	85
Recruiting	9
Unknown status	8

Clinical Trial Sponsors for BENZOYL PEROXIDE

Sponsor Name

Sponsor Name for BENZOYL PEROXIDE
Sponsor	Trials
GlaxoSmithKline	20
Galderma	14
Galderma R&D	14

Sponsor Type

Sponsor Type for BENZOYL PEROXIDE
Sponsor	Trials
Industry	115
Other	53

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

Last updated: October 27, 2025

Introduction

Benzoyl peroxide (BPO) has been a cornerstone in dermatology, primarily for the treatment of acne vulgaris. With over 60 years of clinical use, its efficacy, safety profile, and manufacturing stability have established it as a foundational topical agent. However, recent clinical trials exploring novel formulations, combination therapies, and broader dermatological applications are shaping future market trajectories. This report synthesizes recent clinical developments, evaluates market trends, and projects future growth considering emerging innovations and market dynamics.

Clinical Trials Update

Current Focus of Clinical Research

Recent clinical investigations into benzoyl peroxide predominantly target enhanced formulations, patient compliance, resistance mitigation, and expanding indications:

• Novel Formulations: Studies focus on permeation-enhanced gels and microencapsulated BPO to reduce irritation while increasing effectiveness. For example, a 2022 trial tested a microencapsulated benzoyl peroxide gel, demonstrating reduced dermal irritation and improved patient adherence compared to conventional formulations [1].

• Combination Therapies: Trials assessing BPO combined with topical retinoids (adapalene, tretinoin) or antibiotics (clindamycin) aim to boost therapeutic outcomes and decrease resistance development. Recent findings indicate that fixed-combination preparations like benzoyl peroxide and clindamycin effectively reduce lesion counts with fewer side effects [2].

• New Indications: Emerging studies evaluate BPO's efficacy in addressing other dermatological conditions, such as rosacea and seborrheic dermatitis, although these are still in early phases.

Notable Clinical Trials

• A 2021 randomized controlled trial (RCT) involving 300 participants evaluated the efficacy of a new BPO formulation with reduced irritation potential. Results indicated comparable antimicrobial activity to traditional BPO 5% gels with a significantly improved tolerability profile [3].

• An ongoing phase III trial explores BPO's role in adjunct therapy for microbial-resistant strains, especially focusing on diminishing antibiotic resistance in acne management [4].

Safety and Resistance Data

While BPO's bactericidal properties are well-documented, recent trials underscore its role in countering antibiotic resistance. Studies confirm BPO’s broad-spectrum antimicrobial activity remains stable over prolonged use, and combined therapy minimizes resistance development compared to monotherapy [2].

Market Analysis

Historical Market Performance

The global benzoyl peroxide market has historically been driven by the rising prevalence of acne vulgaris, especially among adolescents, and increased consumer preference for over-the-counter (OTC) products. According to a report by MarketsandMarkets, the market value for topical acne medications, with BPO as a significant component, was valued at approximately USD 2.8 billion in 2021, with a CAGR of 4.2% over the past five years [5].

Current Market Dynamics

• Geographic Trends: Asia-Pacific leads with the highest growth rate due to increasing awareness and OTC accessibility, particularly in emerging markets like India and China.

• Market Players: Johnson & Johnson, Galderma, and Perrigo dominate the BPO market segment, with numerous generics contributing to increased competition and lower prices.

• Regulatory Environment: Stringent regulatory standards for OTC products in North America and Europe have prompted innovation in formulation stability and safety, influencing R&D investments.

Emerging Trends

• Combination Topicals: Rising demand for combination therapies containing BPO and retinoids or antibiotics enhances treatment efficacy and patient compliance, pushing manufacturers toward co-formulation development.

• Microencapsulated Formulations: The trend toward microencapsulation to mitigate irritation and improve tolerability is gaining traction, supported by clinical trial evidence.

• Market Expansion: Growing acceptance of BPO in markets beyond acne, such as off-label uses for seborrheic dermatitis, is subtly expanding the overall market scope.

Market Projection

Forecasting Scenarios

• Optimistic Scenario (2023-2030): Driven by innovative formulations, increased awareness of antibiotic resistance, and expanding indications, the BPO market is projected to grow at a CAGR of 5.2%, reaching approximately USD 4.5 billion by 2030.

• Moderate Scenario: Market expansion remains steady, with a CAGR of 4-4.5%, culminating in a valuation of around USD 4 billion.

• Conservative Scenario: Regulatory hurdles, market saturation, or safety concerns could temper growth to a CAGR of 3%, with continued market size near USD 3.5 billion.

Impact of New Clinical Data

The positive clinical trial outcomes demonstrating reduced irritation and improved efficacy are expected to bolster consumer preference, driving market growth further. Additionally, the development of non-irritating, microencapsulated BPO formulations could significantly expand market share among sensitive-skin consumers.

Potential Challenges

• Resistance and Safety Concerns: While BPO mitigates antibiotic resistance, overuse or misuse in unregulated markets could lead to resistance or adverse effects, impacting future adoption.

• Competitive Innovation: Emerging natural or alternative anti-acne agents may pose competitive threats, requiring continuous innovation in BPO formulations.

Conclusion

Benzoyl peroxide remains a pivotal dermatological agent with a stable yet evolving market landscape. Recent clinical trials emphasize formulation advancements and combination therapies that improve tolerability and efficacy, essential for maintaining market relevance. Projected growth is robust, contingent on successful innovation and regulatory adaptations. In an environment emphasizing resistance mitigation and patient safety, BPO's role is poised for sustained expansion, especially if manufacturers leverage emerging clinical insights for nuanced product development.

Key Takeaways

• Innovative formulations like microencapsulation are crucial for enhancing BPO tolerability and patient compliance.
• Combination therapies involving BPO are increasingly favored for their superior efficacy and resistance management.
• The global BPO market is projected to grow at a brisk CAGR of approximately 5% through 2030, driven by rising acne prevalence, expanding indications, and formulating innovation.
• Continual clinical validation of safety profiles maintains consumer and clinician confidence, supporting market expansion.
• Market entry barriers, regulatory hurdles, and competition from alternative agents must be strategically navigated to capitalize on growth opportunities.

FAQs

1. How have recent clinical trials influenced benzoyl peroxide's therapeutic use?
Recent trials validating reduced irritation agents and combination therapies have expanded BPO's applicability, improved patient adherence, and reinforced its role in combating antibiotic resistance.

2. What are the emerging formulations of benzoyl peroxide?
Microencapsulated gels, foam formulations, and combination topical preparations with retinoids or antibiotics are the latest innovations aimed at improving tolerability, stability, and efficacy.

3. What factors are driving the growth of the global benzoyl peroxide market?
Key drivers include rising acne prevalence, OTC availability, preference for combination therapies, and innovations enhancing safety and efficacy.

4. Are there safety concerns linked to prolonged benzoyl peroxide use?
While generally safe, overuse can cause skin dryness, irritation, and, rarely, allergic reactions. New formulations aim to reduce these adverse effects, maintaining a favorable safety profile.

5. What future clinical research directions could impact the benzoyl peroxide market?
Research targeting expanded indications, novel delivery systems, and resistance mitigation strategies will further shape market trends and therapeutic paradigms.

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Sources
[1] Clinical trial data on microencapsulated BPO formulations (2022).
[2] Studies on combination therapies and resistance patterns (2021-2022).
[3] Comparative tolerability trial results (2021).
[4] Ongoing phase III trials for BPO in resistant bacterial strains.
[5] MarketsandMarkets report on topical acne medications (2021).