Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

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Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CD07223 1.5% gel

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

Group Type EXPERIMENTAL

Epiduo vehicle gel

Intervention Type DRUG

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

CD07223

Intervention Type DRUG

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks

CD07223 0.5% gel

500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

Group Type EXPERIMENTAL

Epiduo vehicle gel

Intervention Type DRUG

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

CD07223

Intervention Type DRUG

500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces

Group Type ACTIVE_COMPARATOR

Epiduo vehicle gel

Intervention Type DRUG

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

Intervention Type DRUG

500 microliters Epiduo Gel on one of the half-face for the morning dose

Interventions

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Epiduo vehicle gel

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

Intervention Type DRUG

CD07223

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks

Intervention Type DRUG

CD07223

500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks

Intervention Type DRUG

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

500 microliters Epiduo Gel on one of the half-face for the morning dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* subject has a clinical diagnosis of acne vulgaris with facial involvement
* the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria

* subject has a severe acne form or secondary acne form
* the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
* the subject has a known allergy or sensitivity to any of the components of the study products
* subject is not willing to respect wash-out periods for topical and/or systemic treatments

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No