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

• ClinicalTrials.gov Identifier: NCT01106807
• Recruitment Status: Completed
• First Posted: April 20, 2010
• Last Update Posted: February 18, 2021
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne	Drug: Epiduo vehicle gel; Drug: CD07223; Drug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
• Study Start Date: April 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

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
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 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

Outcome Measures

Primary Outcome Measures :

1. Total acne lesion count [ Time Frame: 6 weeks ]
   change in total number of acne lesion count from baseline to end of treatment
2. Percent change of acne lesion count [ Time Frame: 6 weeks ]
   Percent change of acne lesion count from baseline to end of treatment

Secondary Outcome Measures :

1. Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
   change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
2. Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
   change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
3. Lesion counts- Inflammatory [ Time Frame: 6 weeks ]
   Percent change of acne lesion count from baseline at each evaluation visit
4. Lesion count- non-inflammatory [ Time Frame: 6 weeks ]
   Percent change of acne lesion count from baseline at each evaluation visit

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arkansas

Burke Pharmaceuticals

Hot Springs, Arkansas, United States

United States, Kentucky

Dermatology Specialist PSC

Louisville, Kentucky, United States, 40202

United States, Michigan

Grekin Skin Institute

Warren, Michigan, United States, 48088

United States, New Jersey

TKL Research

Rochelle Park, New Jersey, United States, 07662

United States, North Carolina

Piedmont Medical Research

Winston-Salem, North Carolina, United States, 27103

United States, North Dakota

Cetero

Fargo, North Dakota, United States, 58104

United States, Texas

Derm Research, Inc

Austin, Texas, United States, 78759

J & S Studies

Bryan, Texas, United States, 77845

United States, Virginia

Education and Research Foundation, Inc

Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Galderma R&D

Investigators

• Study Director: Michael Graeber, MD; Galderma R&D

More Information

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01106807
• Other Study ID Numbers: RD.06.SPR.18173
• First Posted: April 20, 2010
• Last Update Posted: February 18, 2021
• Last Verified: April 2012

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents