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

Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Epiduo vehicle gel; Drug: CD07223; Drug: CD07223; Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Burke Pharmaceuticals
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialist PSC
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • New Jersey
    • Rochelle Park, New Jersey, United States, 07662
      • TKL Research
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Cetero
  • Texas
    • Austin, Texas, United States, 78759
      • Derm Research, Inc
    • Bryan, Texas, United States, 77845
      • J & S Studies
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Education and Research Foundation, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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
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	Drug: Epiduo vehicle gel; 500 microliters of Epiduo vehicle 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total acne lesion count	change in total number of acne lesion count from baseline to end of treatment	6 weeks
Percent change of acne lesion count	Percent change of acne lesion count from baseline to end of treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion counts- Inflammatory	change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject	6 weeks
Lesion count- non-inflammatory	change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject	6 weeks
Lesion counts- Inflammatory	Percent change of acne lesion count from baseline at each evaluation visit	6 weeks
Lesion count- non-inflammatory	Percent change of acne lesion count from baseline at each evaluation visit	6 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: RD.06.SPR.18173