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

Phase 2

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel	Epiduo vehicle 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
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel	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
CD07223 1.5% gel	Epiduo vehicle 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
CD07223 1.5% gel	CD07223	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
CD07223 0.5% gel	Epiduo vehicle 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
CD07223 0.5% gel	CD07223	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

Primary Outcome Measures

Name	Time	Method
Total acne lesion count	6 weeks	change in total number of acne lesion count from baseline to end of treatment
Percent change of acne lesion count	6 weeks	Percent change of acne lesion count from baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
Lesion counts- Inflammatory	6 weeks	Percent change of acne lesion count from baseline at each evaluation visit
Lesion count- non-inflammatory	6 weeks	Percent change of acne lesion count from baseline at each evaluation visit

Locations (9): J & S Studies
🇺🇸
Bryan, Texas, United States
Cetero
🇺🇸
Fargo, North Dakota, United States
Burke Pharmaceuticals
🇺🇸
Hot Springs, Arkansas, United States
TKL Research
🇺🇸
Rochelle Park, New Jersey, United States
Education and Research Foundation, Inc
🇺🇸
Lynchburg, Virginia, United States
Grekin Skin Institute
🇺🇸
Warren, Michigan, United States
Dermatology Specialist PSC
🇺🇸
Louisville, Kentucky, United States
Piedmont Medical Research
🇺🇸
Winston-Salem, North Carolina, United States
Derm Research, Inc
🇺🇸
Austin, Texas, United States