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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	New York University School of Medicine	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne	Withdrawn	NYU Langone Health	N/A	2018-08-07	This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena®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

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.

Clinical Trial Conditions for BENZOYL PEROXIDE

Condition Name

Condition Name for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	73
Acne	14
Foot Dermatoses	3

Condition MeSH

Condition MeSH for BENZOYL PEROXIDE
Intervention	Trials
Acne Vulgaris	88
Skin Diseases	4
Foot Dermatoses	3

Clinical Trial Locations for BENZOYL PEROXIDE

Trials by Country

+

−

Trials by Country for BENZOYL PEROXIDE
Location	Trials
United States	241
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	14

Clinical Trial Progress for BENZOYL PEROXIDE

Clinical Trial Phase

Clinical Trial Phase for BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Phase 4	47
Phase 3	30
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for BENZOYL PEROXIDE
Clinical Trial Phase	Trials
Completed	82
Recruiting	8
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	111
Other	50

Benzoyl Peroxide: Clinical Trials, Market Analysis, and Projections

Introduction to Benzoyl Peroxide

Benzoyl peroxide is a widely used chemical with diverse applications, including its role as an antibiotic, bleaching agent, and most notably, in the treatment of acne. This article delves into the latest clinical trials, market analysis, and projections for benzoyl peroxide, highlighting its safety, market trends, and future outlook.

Clinical Trials and Safety Concerns

Recent Safety Concerns and Research

In March 2024, a report by Valisure raised concerns about the presence of benzene, a potential carcinogen, in benzoyl peroxide products due to thermal decomposition at high temperatures. This prompted a thorough examination of the safety of benzoyl peroxide.

• Blood Benzene Levels: A study using data from the National Health and Nutrition Examination Survey (NHANES) compared blood benzene levels in individuals using benzoyl peroxide products with those who did not. The study found no detectable differences in benzene levels between the two groups, suggesting that benzoyl peroxide use does not lead to increased benzene levels in the body[1].

• Long-term Cancer Risk Assessment: Another study, utilizing data from TriNetX, monitored a cohort of over 50,000 individuals for 10 years. This research did not identify any increased risk of malignancy, including leukemia, lymphoma, or solid organ tumors, among benzoyl peroxide users. This reinforces the safety of benzoyl peroxide in clinical practice[1].

Alternatives to Benzoyl Peroxide

Given the concerns about benzene, companies are exploring alternatives to benzoyl peroxide. For instance, Lindus Health and Acinonyx Bio are partnering in a clinical trial to evaluate a safer alternative for inflammatory acne. This move is driven by the need to address the potential risks associated with benzoyl peroxide, particularly the presence of benzene at room temperature and higher temperatures[4].

Market Analysis

Market Size and Growth

The benzoyl peroxide market is projected to experience significant growth over the next few years. Here are some key market projections:

• Market Size: The global benzoyl peroxide market was valued at USD 15.59 KT in 2023 and is expected to grow to USD 21.00 KT by 2030, at a CAGR of 4.35% during the forecast period[3].

• Revenue Projections: Another report estimates the market size to reach USD 1,341.92 million by 2030, growing at a CAGR of 5.59% from 2023[5].

• Segment Analysis: The industrial grade segment holds the largest share in the benzoyl peroxide market, driven by its versatile applications in the chemical and plastics industry, including roles as polymerization initiators, bleaching agents, and cross-linking agents[2].

Market Drivers

Several factors are driving the growth of the benzoyl peroxide market:

• Growing Skincare Industry: The escalating number of acne cases, influenced by genetics, sensitive skin, stressful lifestyles, and increasing obesity rates, particularly in North America, contributes to a growing demand for benzoyl peroxide[2].

• Diverse Applications: Besides its primary use in acne treatment, benzoyl peroxide is used in various bleaching processes, such as floor, hair, teeth, and textile bleaching. Its effectiveness in these applications further boosts market demand[2][3].

• Geographical Trends: The North American region holds a significant share in the benzoyl peroxide market, driven by the robust growth of the processed food industry and the need for effective acne treatments[2].

Market Challenges

Despite the growth prospects, the benzoyl peroxide market faces several challenges:

• Side Effects: Benzoyl peroxide can cause side effects such as burning, itching, and peeling, and it has teratogenic effects, making it unsuitable for pregnant women. These factors are expected to hinder market growth[3].

• Alternatives and Substitutes: The availability of substitutes like niacinamide, salicylic acid, glycolic acid, and azelaic acid is disrupting the competitive structure of the market, posing a challenge to vendors[3].

Market Segmentation

By Quality Index

The benzoyl peroxide market is segmented by quality index into reagent grade, food grade, industrial grade, and others. The industrial grade segment dominates the market due to its widespread applications in the chemical and plastics industry[2].

By Appearance

Benzoyl peroxide is available in various forms such as powder, grain, crystal, and paste. Each form has specific applications, with the powder form being particularly popular for flour bleaching due to its gradual bleaching effect over several days[2].

By End Users

The market is segmented by end users into the chemical and plastics industry, general industry, building and construction, automotive and transportation, and others. The chemical and plastics industry holds a significant share due to the diverse applications of benzoyl peroxide in this sector[2].

Geographical Analysis

North American Region

The North American region, particularly the United States, is a key market for benzoyl peroxide. The region's demand is driven by the growing skincare industry and the robust growth of the processed food sector. The use of benzoyl peroxide in flour bleaching, for instance, is a significant factor contributing to its demand in this region[2].

Future Outlook

Market Projections

The benzoyl peroxide market is expected to grow steadily over the next few years, driven by its diverse applications and the growing demand for effective acne treatments. Here are some key projections:

• Market Size by 2030: The market is projected to reach USD 1,341.92 million by 2030, growing at a CAGR of 5.59% from 2023[5].

• CAGR: The market is expected to grow at a CAGR of 4.35% to 5.59% during the forecast period, depending on the source[3][5].

Addressing Safety Concerns

To address the safety concerns related to benzene, manufacturers and users are advised to keep benzoyl peroxide products refrigerated, renew the medicine every 3 to 6 months, and avoid heated storage. These measures can help slow the decomposition of benzoyl peroxide and reduce the formation of benzene[4].

Key Takeaways

• Safety: Recent studies have shown that benzoyl peroxide does not increase blood benzene levels or long-term cancer risk, reassuring its safety in clinical practice.
• Market Growth: The benzoyl peroxide market is projected to grow significantly, driven by its diverse applications and the growing skincare industry.
• Challenges: The market faces challenges from side effects, teratogenic effects, and the availability of substitutes.
• Geographical Trends: The North American region is a key market, driven by the processed food industry and skincare needs.
• Future Outlook: The market is expected to continue growing, with a focus on addressing safety concerns related to benzene.

FAQs

Q: What are the primary concerns regarding the safety of benzoyl peroxide?

A: The primary concerns include the presence of benzene, a potential carcinogen, due to thermal decomposition at high temperatures. However, recent studies have reassured its safety in clinical practice[1][4].

Q: What are the main applications of benzoyl peroxide?

A: Benzoyl peroxide is used as an antibiotic, in various bleaching processes (floor, hair, teeth, textile), and primarily in the treatment of acne[2][3].

Q: How is the benzoyl peroxide market segmented?

A: The market is segmented by quality index, appearance, and end users, with the industrial grade segment and chemical and plastics industry holding significant shares[2].

Q: What are the key drivers of the benzoyl peroxide market?

A: The growing skincare industry, diverse applications, and robust growth of the processed food sector are key drivers of the market[2].

Q: Are there any alternatives to benzoyl peroxide being developed?

A: Yes, companies like Lindus Health and Acinonyx Bio are working on safer alternatives to benzoyl peroxide due to concerns about benzene[4].

References

1. Examining Benzene in Benzoyl Peroxide: Insights into the Latest Research. Dermsquared.
2. Benzoyl Peroxide Market - Forecast(2024-2030) Research Report. IndustryARC.
3. Benzoyl Peroxide Market : Global Industry Analysis Forecast. Maximize Market Research.
4. Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative. Dermatology Times.
5. Benzoyl Peroxide Market Size & Share 2025-2030. 360 Research Reports.