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Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR BENZACLIN


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All Clinical Trials for BENZACLIN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01237821 ↗ Comparing OTC Acne Treatment to Prescription Regimen Completed Loreal USA N/A 2010-10-01 This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.
NCT01138514 ↗ Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels Completed Padagis LLC Phase 3 2009-10-01 The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
NCT01138514 ↗ Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels Completed Perrigo Company Phase 3 2009-10-01 The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for BENZACLIN

Condition Name

4000.511.522.533.54Acne Vulgaris[disabled in preview]
Condition Name for BENZACLIN
Intervention Trials
Acne Vulgaris 4
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Condition MeSH

4000.511.522.533.54Acne Vulgaris[disabled in preview]
Condition MeSH for BENZACLIN
Intervention Trials
Acne Vulgaris 4
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Clinical Trial Locations for BENZACLIN

Trials by Country

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Trials by Country for BENZACLIN
Location Trials
United States 8
Belize 1
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Trials by US State

+
Trials by US State for BENZACLIN
Location Trials
Pennsylvania 2
California 1
New York 1
Tennessee 1
South Carolina 1
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Clinical Trial Progress for BENZACLIN

Clinical Trial Phase

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 3Phase 1N/A[disabled in preview]
Clinical Trial Phase for BENZACLIN
Clinical Trial Phase Trials
Phase 3 2
Phase 1 1
N/A 1
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Clinical Trial Status

100.0%000.511.522.533.54Completed[disabled in preview]
Clinical Trial Status for BENZACLIN
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for BENZACLIN

Sponsor Name

trials000001111111Perrigo CompanyLoreal USAMilton S. Hershey Medical Center[disabled in preview]
Sponsor Name for BENZACLIN
Sponsor Trials
Perrigo Company 1
Loreal USA 1
Milton S. Hershey Medical Center 1
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Sponsor Type

83.3%16.7%0-0.500.511.522.533.544.555.5IndustryOther[disabled in preview]
Sponsor Type for BENZACLIN
Sponsor Trials
Industry 5
Other 1
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BenzaClin: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to BenzaClin

BenzaClin Topical Gel is a widely used treatment for acne vulgaris, combining clindamycin phosphate 1% and benzoyl peroxide 5%. This dual-action gel has been extensively studied and proven effective in reducing acne lesions.

Clinical Trials and Efficacy

Study Outcomes

Clinical trials have consistently shown the efficacy of BenzaClin in treating acne. A 10-week evaluator-blind, multi-center trial involving 132 patients compared the efficacy of BenzaClin alone against a combination of tretinoin 0.025% gel plus clindamycin 1% gel, and a combination of BenzaClin plus tretinoin 0.025% gel plus clindamycin 1% gel. The results indicated that patients using BenzaClin alone had a numerically greater reduction in acne lesions compared to the other treatment groups[1].

In another study, BenzaClin demonstrated significant improvements in reducing both inflammatory and non-inflammatory acne lesions. Patients treated with BenzaClin showed a mean percent reduction in inflammatory lesion counts of 63%, and in non-inflammatory lesion counts of 54%, which was greater than the reductions seen in the benzoyl peroxide, clindamycin, and vehicle groups[3][4].

Rapid Onset of Action

BenzaClin has been noted for its rapid onset of action. By the second week of the study, patients receiving BenzaClin alone showed statistically significant improvements in the reduction of inflammatory lesions compared to other treatment groups[1].

Adverse Events

The most frequently reported adverse event in the BenzaClin treatment group was dry skin, occurring in 12% of patients. Other local adverse events included itching, burning, and erythema, though these were less common[3][4].

Market Analysis

Market Size and Growth

The market for benzoyl peroxide, a key component of BenzaClin, is projected to grow significantly. By 2030, the benzoyl peroxide market is forecast to reach $462.5 million, growing at a CAGR of 3.56% from 2024 to 2030. This growth is driven by the increasing demand for effective acne treatments, particularly among teenagers and young adults[2].

Regional Demand

North America has witnessed the highest growth in the benzoyl peroxide market, with a market share of 32% in 2023. The demand in this region is driven by the effectiveness of benzoyl peroxide as a bleaching agent and its widespread use in skincare products[2].

Driving Factors

The market for clindamycin phosphate and benzoyl peroxide is expected to reach USD 322.8 million by 2029, growing at a CAGR of 6.2%. Key driving factors include the rising demand for personalized skincare solutions and advancements in drug delivery technologies[5].

Market Segments

End Users

The benzoyl peroxide market is segmented by end users, with the pharmaceutical sector being the primary user due to its efficacy in treating acne. Other segments include the chemical and plastics industry, where benzoyl peroxide is used in various bleaching processes[2].

Geographic Distribution

The market is also segmented geographically, with North America, Europe, Asia-Pacific, South America, and the Rest of the World being key regions. North America leads in market share due to high demand for acne treatments and other applications of benzoyl peroxide[2].

Projections and Future Outlook

Market Expansion

The escalating number of acne cases, influenced by factors such as genetics, sensitive skin, stressful lifestyles, and increasing obesity rates, contributes to a growing demand for benzoyl peroxide and clindamycin phosphate. This trend is expected to continue, driving market expansion in the forecast period[2][5].

Technological Advancements

Advancements in drug delivery technologies are expected to further boost the market. Innovations in formulations and delivery systems could enhance the efficacy and user experience of products like BenzaClin, attracting more consumers and expanding market share[5].

Key Takeaways

  • Clinical Efficacy: BenzaClin has been proven effective in reducing both inflammatory and non-inflammatory acne lesions, with a rapid onset of action.
  • Market Growth: The benzoyl peroxide market is projected to grow at a CAGR of 3.56% from 2024 to 2030, reaching $462.5 million by 2030.
  • Regional Demand: North America leads in market share due to high demand for acne treatments and other applications of benzoyl peroxide.
  • Driving Factors: Rising demand for personalized skincare solutions and advancements in drug delivery technologies are key drivers of the market.
  • Future Outlook: The market is expected to expand driven by increasing acne cases and technological advancements.

FAQs

What is the primary indication for BenzaClin Topical Gel?

BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris[3][4].

What are the common adverse events associated with BenzaClin?

The most frequently reported adverse event is dry skin, occurring in 12% of patients. Other local adverse events include itching, burning, and erythema[3][4].

How does BenzaClin compare to other acne treatments in clinical trials?

BenzaClin has shown greater overall improvement compared to benzoyl peroxide, clindamycin, and vehicle groups in reducing acne lesions[1][3][4].

What is the projected market size for the benzoyl peroxide market by 2030?

The benzoyl peroxide market is forecast to reach $462.5 million by 2030, growing at a CAGR of 3.56% from 2024 to 2030[2].

What are the key driving factors for the clindamycin phosphate and benzoyl peroxide market?

The key driving factors include the rising demand for personalized skincare solutions and advancements in drug delivery technologies[5].

Sources

  1. Sanofi-Aventis (France) Release: Study Demonstrates ... - BioSpace
  2. Benzoyl Peroxide Market - Forecast(2021-2026) Research Report
  3. BenzaClin Topical Gel - accessdata.fda.gov
  4. BenzaClin Topical Gel - accessdata.fda.gov
  5. Clindamycin Phosphate and Benzoyl Peroxide Market 2032

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