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

• Total acne lesion count [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  change in total number of acne lesion count from baseline to end of treatment
• Percent change of acne lesion count [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  Percent change of acne lesion count from baseline to end of treatment

• Lesion counts- Inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
• Lesion count- non-inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
• Lesion counts- Inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  Percent change of acne lesion count from baseline at each evaluation visit
• Lesion count- non-inflammatory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  Percent change of acne lesion count from baseline at each evaluation visit

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.

• Drug: Epiduo vehicle gel
  500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
• Drug: CD07223
  500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
• Drug: CD07223
  500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
• 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

• Experimental: 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
  Interventions:

  • Drug: Epiduo vehicle gel
  • Drug: CD07223
• Experimental: 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
  Interventions:

  • Drug: Epiduo vehicle gel
  • Drug: CD07223
• Active Comparator: 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
  Interventions:

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

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