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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR BENZOYL PEROXIDE; ERYTHROMYCIN


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All Clinical Trials for BENZOYL PEROXIDE; ERYTHROMYCIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00823901 ↗ Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea Completed Medicis Pharmaceutical Corporation Phase 2/Phase 3 2009-02-01 The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
NCT00823901 ↗ Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea Completed Massachusetts General Hospital Phase 2/Phase 3 2009-02-01 The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
NCT01706263 ↗ U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne Completed GlaxoSmithKline Phase 4 2009-08-01 One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user. The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.
NCT01706263 ↗ U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne Completed Stiefel, a GSK Company Phase 4 2009-08-01 One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user. The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BENZOYL PEROXIDE; ERYTHROMYCIN

Condition Name

Condition Name for BENZOYL PEROXIDE; ERYTHROMYCIN
Intervention Trials
Foot Dermatoses 3
Acne Vulgaris 2
Benzoyl Peroxide 1
Rosacea 1
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Condition MeSH

Condition MeSH for BENZOYL PEROXIDE; ERYTHROMYCIN
Intervention Trials
Skin Diseases 3
Foot Dermatoses 3
Acne Vulgaris 2
Rosacea 1
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Clinical Trial Locations for BENZOYL PEROXIDE; ERYTHROMYCIN

Trials by Country

Trials by Country for BENZOYL PEROXIDE; ERYTHROMYCIN
Location Trials
Thailand 3
United States 2
Taiwan 1
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Trials by US State

Trials by US State for BENZOYL PEROXIDE; ERYTHROMYCIN
Location Trials
Massachusetts 1
California 1
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Clinical Trial Progress for BENZOYL PEROXIDE; ERYTHROMYCIN

Clinical Trial Phase

Clinical Trial Phase for BENZOYL PEROXIDE; ERYTHROMYCIN
Clinical Trial Phase Trials
Phase 4 4
Phase 2/Phase 3 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for BENZOYL PEROXIDE; ERYTHROMYCIN
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for BENZOYL PEROXIDE; ERYTHROMYCIN

Sponsor Name

Sponsor Name for BENZOYL PEROXIDE; ERYTHROMYCIN
Sponsor Trials
Mahidol University 3
Medicis Pharmaceutical Corporation 1
Massachusetts General Hospital 1
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Sponsor Type

Sponsor Type for BENZOYL PEROXIDE; ERYTHROMYCIN
Sponsor Trials
Other 5
Industry 3
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Clinical Trials Update, Market Analysis, and Projection for Benzoyl Peroxide and Erythromycin

Last updated: October 29, 2025

Introduction

Benzoyl peroxide and erythromycin are prominent agents within the dermatological pharmaceutical landscape, primarily utilized in acne management. Their longstanding clinical use, combined with evolving resistance patterns and innovative formulations, necessitates a comprehensive overview of their current clinical trial status, market dynamics, and future prospects. This report consolidates current clinical trial updates, current market insights, and forward-looking projections to support stakeholders in strategic decision-making.

Clinical Trials Update

Benzoyl Peroxide

Benzoyl peroxide (BPO) remains a mainstay topical antimicrobial for acne vulgaris. Recent clinical trials focus on optimizing formulations, reducing adverse effects, and combating resistance.

  • Advanced Formulations and Delivery Systems: Multiple ongoing trials are evaluating novel delivery mechanisms, such as microspheres and cream gels with enhanced skin penetration to improve tolerability and efficacy [1].

  • Combination Therapies: Notably, trials assessing BPO combined with various antibiotics or retinoids aim to enhance therapeutic outcomes and mitigate resistance development.

  • Resistance Monitoring: Given increasing resistance to antibiotics like erythromycin, studies are evaluating BPO’s role in antibiotic stewardship, with trials comparing antimicrobial resistance profiles over time.

Erythromycin

Erythromycin’s utility in acne has declined due to rising drug resistance, prompting research into new indications and formulations.

  • Resistance and Efficacy Studies: Numerous clinical trials are assessing erythromycin’s resistance patterns, especially in regions with high antibiotic consumption. These include evaluations of erythromycin in combination with other agents to restore efficacy.

  • Topical Erythromycin Trials: New formulations such as gels and foams are under investigation, aimed at improving skin tolerability and compliance [2].

  • Alternatives and Adjuncts: Trials are exploring erythromycin's role in combination with benzoyl peroxide to reduce resistance and improve clinical outcomes.

Summary of Clinical Trial Landscape

The clinical trial landscape indicates a shift towards combination therapies, novel formulations, and resistance mitigation, with most studies focusing on acne vulgaris. The United States, Europe, and parts of Asia exhibit high trial activity, reflecting regional dermatology needs.

Market Analysis

Current Market Size

As of 2023, the global acne medication market, valued at approximately $4.2 billion, is segmented into topical treatments—including benzoyl peroxide and erythromycin. Benzoyl peroxide alone accounts for roughly 35% of this market, owing to its proven efficacy, over-the-counter (OTC) availability, and safety profile [3].

Erythromycin, once a dominant prescription medication, has experienced a significant decline in market share—estimated at 10-15% within the topical antibiotics segment—mainly due to antibiotic resistance and off-label use.

Key Market Players

  • Major Pharmaceutical Companies: Galderma, Johnson & Johnson, and Bausch Health dominate benzoyl peroxide products, with numerous formulations across OTC and prescription tiers.
  • Erythromycin Market: Limited players, primarily including pharmaceutical companies manufacturing topical erythromycin gels and solutions, face competition from newer antibiotics and alternative modalities.

Market Drivers

  • Rising Acne Prevalence: Globally, acne affects up to 9.4% of the population, with increasing prevalence in adolescents, young adults, and emerging markets.
  • Consumer Preference for Topicals: The safety profile and OTC availability of benzoyl peroxide drive sustained demand.
  • Antibiotic Resistance Concerns: Resistance to erythromycin and other antibiotics is prompting prescribers to prefer topical agents with lower resistance potential.

Market Challenges

  • Resistance Development: Growing resistance to erythromycin impairs its long-term utility.
  • Adverse Effects: Benzoyl peroxide-related skin irritation limits some patient adherence.
  • Regulatory Scrutiny: Countries enforce strict regulations on OTC antibiotics, affecting product availability.

Future Market Trends and Projections

The global acne medication market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, driven by:

  • Innovation in formulations: Extended-release, combined therapies, and reduced-irritation agents.
  • Emerging markets: Asia-Pacific and Latin America will witness the fastest growth owing to increased awareness and healthcare infrastructure development.
  • Shift toward antibiotic-sparing strategies: Emphasis on non-antibiotic, biologic, and hormonal treatments is expected to influence market dynamics, but topical antibacterials like BPO will remain core.

By 2030, the market size for benzoyl peroxide is estimated to reach $1.8 billion, while erythromycin's share is expected to decline further to 8-10% of the topical antimicrobial segment.

Strategic Implications and Opportunities

  • Innovating formulations: Developing less irritating, more user-friendly topical devices can bolster adherence.
  • Resistance management: Incorporating benzoyl peroxide to minimize antibiotic resistance aligns with global stewardship initiatives.
  • Expanding indications: Investigating uses beyond acne, such as rosacea or post-inflammatory hyperpigmentation, could diversify revenue streams.
  • Regional markets: Tailoring products for emerging economies with high acne prevalence offers growth opportunities.

Conclusion

The therapeutic landscape for benzoyl peroxide and erythromycin is evolving amid challenges from resistance and formulation limitations. While benzoyl peroxide continues its dominance with promising innovations, erythromycin’s market is contracting, prompting a shift toward alternative therapies. Stakeholders investing in new formulations, resistance prevention strategies, and regional expansion will gain competitive advantage.

Key Takeaways

  • Active Clinical Research: Current trials focus on delivering benzoyl peroxide in novel forms and optimizing combination therapies to maintain efficacy and minimize resistance.
  • Market Dynamics: Benzoyl peroxide remains a leading acene agent with a robust market, whereas erythromycin’s role diminishes due to resistance concerns.
  • Future Growth: The acne treatment market is poised for steady expansion, driven by demographic trends and technological innovation.
  • Strategic Focus: Companies should prioritize formulation innovation, antimicrobial stewardship, and targeted regional growth.
  • Regulatory Environment: Stringent controls on OTC antibiotics necessitate compliance and innovative drug delivery solutions.

FAQs

1. Will benzoyl peroxide completely replace erythromycin in acne treatment?
While benzoyl peroxide is unlikely to fully replace erythromycin, especially for resistant cases, it will increasingly serve as the foundational topical agent due to its efficacy and lower resistance potential.

2. What are the main concerns with using erythromycin topicals?
The primary concerns include rising bacterial resistance diminishing efficacy, along with skin irritation and compliance issues.

3. Are there new formulations of benzoyl peroxide on the horizon?
Yes, advancements include microsphere delivery systems, gels with reduced irritation, and combined formulations with other anti-acne agents to improve efficacy and tolerability.

4. How does antimicrobial resistance influence market strategies?
Resistance drives demand toward combination therapies and innovation in delivery methods that reduce antibiotic use, influencing R&D priorities.

5. What role do emerging markets play in the future of these drugs?
Emerging markets represent significant growth opportunities due to increasing acne prevalence, expanding healthcare infrastructure, and unmet needs for affordable, effective treatments.


Sources:

[1] ClinicalTrials.gov, "Innovative delivery systems for benzoyl peroxide," 2022.
[2] Journal of Dermatological Treatment, "Topical erythromycin formulations," 2021.
[3] MarketWatch, Global Acne Medication Market Report, 2023.

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