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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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

Condition Name

Condition Name for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	80
Acne	14
Foot Dermatoses	3
Surgical Site Infection	2

Condition MeSH

Condition MeSH for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	95
Skin Diseases	4
Communicable Diseases	3
Foot Dermatoses	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	3
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	86
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	54

BENZOYL PEROXIDE: Clinical Trials Update, Market Analysis, and Projections

Last updated: April 26, 2026

What is benzoyl peroxide and what are the clinical trial signals?

Benzoyl peroxide (BPO) is a topical antimicrobial used primarily for acne. It is marketed as drug-device and drug products (e.g., gels, creams, washes) across major regions with long-standing commercialization. Because BPO is an established active ingredient with extensive legacy use, current clinical-trial activity is typically focused on new formulations, delivery systems, combination products, bioequivalence, and comparative effectiveness rather than on de novo mechanism-of-action development.

Trial landscape (what trials usually look like for BPO)

Across acne-focused pipelines, BPO studies generally fall into these buckets:

• Formulation trials: new BPO concentrations, vehicles, and controlled-release or microencapsulation approaches.
• Combination trials: BPO combined with topical actives (for example, antibiotics, retinoids, or anti-inflammatory agents depending on jurisdiction and product).
• Comparative and tolerability trials: head-to-head or vehicle-controlled designs measuring lesion counts and patient-reported outcomes.
• Bridging/bioequivalence: often used for generics, authorized reformulations, or regional submissions.

Practical implication for “clinical trials update”

For BPO, the most decision-relevant “clinical update” is less about discovering a new therapeutic claim and more about:

• Local regulatory compliance evidence (vehicle equivalence, exposure, irritation profile, and comparative clinical endpoints).
• Real-world differentiation driven by formulation (spreadability, irritation mitigation, stability, cosmetically elegant bases).

Note: A market-grade, drug-specific clinical trials update requires a live registry pull (ClinicalTrials.gov, EU CTR, WHO ICTRP) with trial-level identifiers, dates, endpoints, and statuses. No registry data was provided in the prompt, so a fully sourced, trial-by-trial update cannot be produced under strict evidence rules.

Where is benzoyl peroxide sold and how does pricing usually behave?

BPO is widely sold as OTC and prescription-dependent in different markets, typically in:

• Topical leave-on products (gels/creams/lotions)
• Topical wash products (cleansers)
• Fixed-dose combination products (jurisdiction- and brand-dependent)

Pricing behavior is shaped by:

• Competition from generics and multiple concentrations
• Broad payer coverage where reimbursed (varies by country)
• Brand differentiation through tolerability and cosmetic acceptability

Because BPO is off-patent for the active in most geographies, market entry risk is lower for entrants who can meet formulation and regulatory requirements, but differentiation must come from formulation and distribution, not core IP.

What is the market model for BPO in acne and how is demand formed?

Demand for BPO tracks acne prevalence and the dermatology self-care channel mix:

• Acne prevalence and treatment adherence: BPO use is limited by tolerability (dryness, irritation), so “skin feel” impacts stickiness.
• Shift toward combination and anti-irritant vehicles: reformulations target reduced erythema and peeling.
• OTC availability: in many markets, BPO competes in the same shelf-space as salicylic acid, sulfur, adapalene, and benzoyl peroxide variants.

Market drivers that tend to matter

The most consistent demand drivers across topical acne actives are:

• Visibility and retail accessibility (OTC channel)
• Speed of lesion reduction versus tolerability trade-off
• Dermatology guideline alignment (BPO is standard in acne regimens)
• Expansion of regimen bundles (cleanser + leave-on combination packs)

Market constraints

• Irritation and discontinuation: drives switching to better-tolerated regimens.
• Generic penetration: reduces pricing power.
• Regulatory and labeling differences: can affect permissible concentrations and combination claims.

What are the IP and competitive dynamics?

BPO is not typically governed by active-substance composition patents in current commercial markets. Competitive advantage is commonly held via:

• Formulation IP (vehicle, dispersion technology, stability, controlled release)
• Combination-product IP (specific ratios, dosing schedules, and clinical substantiation for a particular product)
• Brand trade dress and patient-facing education (fewer regulatory hurdles once a formulation is established)

In practical investment terms, upside comes from:

• Proprietary platform formulations
• Distribution partnerships
• Localized regulatory strategy

What is the market size and growth outlook?

A precise market size and forecast for BPO requires data inputs: category definition (benzoyl peroxide only vs acne topical market vs acne combination products), geography, segmentation (OTC vs Rx), and source datasets (IQVIA, GlobalData, Statista, etc.). The prompt does not provide any market dataset or citations, and no live retrieval is available here. Under strict evidence rules, a quantified market forecast cannot be produced without verifiable source figures.

How should projections be built for an investor or R&D planner?

Even without a sourced numeric forecast, a robust projection framework for BPO can be built on structure that maps directly to revenue realization:

1) Revenue = Unit demand × Net price

For BPO, unit demand tracks:

• Total acne-treated population proxy (derm visits, OTC regimen users, adherence proxies)
• Channel share of OTC acne products
• Product stickiness driven by tolerability and formulation

Net price is determined by:

• Generic competition intensity
• Pack size and regimen bundling
• Retail and wholesaler margins
• Country-specific reimbursement rules (where applicable)

2) Product strategy levers

For BPO, differentiation levers that move revenue in a market filled with generics are:

• Lower irritation vehicles (reduce discontinuation)
• Higher patient preference (cosmetic elegance)
• Combination positioning (aligned with guideline sequencing)
• Form-factor expansion (washes and targeted leave-on variants)

3) Clinical evidence strategy

BPO product claims are typically supported by:

• Lesion count improvements in mild to moderate acne populations
• Time to noticeable improvement
• Tolerability metrics (erythema, dryness, scaling)
• Patient-reported outcomes (itch/burning, satisfaction)

This is where trial execution affects adoption more than new mechanism claims.

What regulatory and guideline factors affect uptake?

Guidelines for acne management commonly position benzoyl peroxide as a core therapy due to antibacterial and anti-inflammatory activity and its role in combination regimens. Regulatory posture for OTC vs Rx status varies by region and concentration.

Labeling and tolerability claims that drive adoption

For BPO products, commercial differentiation often depends on:

• “Non-comedogenic” or similar vehicle claims where applicable
• Irritation mitigation claims backed by comparative tolerability studies
• Combination regimen schedules

What should a “clinical trials update” deliver for BPO?

For a decision-grade update, it should include:

• Trial IDs and recruitment/completion dates
• Arm design (vehicle control vs active comparator)
• Primary endpoints (inflammatory and non-inflammatory lesion counts, percent change from baseline)
• Safety endpoints (erythema, dryness, peeling)
• Product details (concentration, vehicle, dosing frequency)
• Status (completed, recruiting, active not recruiting)

A sourced list of these items requires registries and sponsor documentation. No trial identifiers were provided in the prompt, so a data-complete update cannot be generated under strict evidence requirements.

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Key Takeaways

• Benzoyl peroxide is an established topical acne active; most current development is driven by formulation and combination-product innovation, not new clinical mechanism claims.
• Clinical value for BPO tends to concentrate on tolerability, vehicle performance, and comparative efficacy that improves adherence.
• Market entry is constrained less by active-substance IP and more by formulation IP, regulatory evidence, and distribution execution.
• A numeric market size and forecast require sourced datasets and a clear category definition; none were provided here, so quantified projections are not produced.

FAQs

1. Is benzoyl peroxide mainly prescription or OTC?
   It is OTC in many markets, while some higher-strength or specific formulations may be prescription-dependent depending on country rules.

2. What endpoints matter most in benzoyl peroxide acne trials?
   Typically inflammatory and non-inflammatory lesion counts, time-to-improvement, and tolerability endpoints such as erythema and dryness.

3. Why do new benzoyl peroxide products still run clinical trials?
   Most trials support new formulations, combination regimens, and bridging for regulatory approval, focusing on efficacy and irritation profile.

4. What drives revenue growth for benzoyl peroxide brands versus generics?
   Better tolerability vehicles, preferred cosmetic feel, combination positioning, and strong retail or dermatologist distribution.

5. Is there meaningful patent protection for benzoyl peroxide itself?
   The active is widely off-patent in major markets; competitive differentiation commonly relies on formulation and product-specific IP rather than novel active-substance patents.

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References

[1] American Academy of Dermatology. “Acne.” Clinical guidance and patient information resources.
[2] PubChem. Benzoyl peroxide. Compound overview and safety information.
[3] ClinicalTrials.gov. Benzoyl peroxide search results (registry for trial identifiers, statuses, and endpoints).
[4] European Medicines Agency (EMA). Public information and product assessment resources (where applicable by formulation).