Comparing OTC Acne Treatment to Prescription Regimen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BenzaClin

Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments

Group Type ACTIVE_COMPARATOR

BenzaClin

Intervention Type DRUG

Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks

effaclar

Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments

Group Type ACTIVE_COMPARATOR

Effaclar

Intervention Type DRUG

Topical, Bid, 12 weeks

Interventions

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BenzaClin

Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks

Intervention Type DRUG

Effaclar

Topical, Bid, 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes