Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
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ClinicalTrials.gov Identifier: NCT01106807 |
Recruitment Status :
Completed
First Posted : April 20, 2010
Last Update Posted : February 18, 2021
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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 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 |
Arm | Intervention/treatment |
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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
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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
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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
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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 |
- Total acne lesion count [ Time Frame: 6 weeks ]change in total number of acne lesion count from baseline to end of treatment
- Percent change of acne lesion count [ Time Frame: 6 weeks ]Percent change of acne lesion count from baseline to end of treatment
- 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
- 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
- Lesion counts- Inflammatory [ Time Frame: 6 weeks ]Percent change of acne lesion count from baseline at each evaluation visit
- Lesion count- non-inflammatory [ Time Frame: 6 weeks ]Percent change of acne lesion count from baseline at each evaluation visit

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106807
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 |
Study Director: | Michael Graeber, MD | Galderma R&D |
Responsible Party: | Galderma R&D |
ClinicalTrials.gov Identifier: | NCT01106807 |
Other Study ID Numbers: |
RD.06.SPR.18173 |
First Posted: | April 20, 2010 Key Record Dates |
Last Update Posted: | February 18, 2021 |
Last Verified: | April 2012 |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Adapalene Adapalene, Benzoyl Peroxide Drug Combination Benzoyl Peroxide Dermatologic Agents |
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 |