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

Galderma

Status and phase: Completed; Phase 2

Conditions: Acne

Treatments: Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel; Drug: CD07223; Drug: Epiduo vehicle gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106807

RD.06.SPR.18173

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 3 patient groups

CD07223 1.5% gel

Experimental group

Description:

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

Treatment:

Drug: CD07223

Drug: CD07223

Drug: Epiduo vehicle gel

CD07223 0.5% gel

Experimental group

Description:

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

Treatment:

Drug: CD07223

Drug: CD07223

Drug: Epiduo vehicle gel

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

Active Comparator group

Description:

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

Treatment:

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

Drug: Epiduo vehicle gel