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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01106807
Other study ID # RD.06.SPR.18173
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2010
Est. completion date September 2010

Study information

Verified date April 2012
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Completed
Enrollment 73
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Epiduo vehicle gel
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
CD07223
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
CD07223
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
500 microliters Epiduo Gel on one of the half-face for the morning dose

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total acne lesion count change in total number of acne lesion count from baseline to end of treatment 6 weeks
Primary Percent change of acne lesion count Percent change of acne lesion count from baseline to end of treatment 6 weeks
Secondary 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
Secondary 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
Secondary Lesion counts- Inflammatory Percent change of acne lesion count from baseline at each evaluation visit 6 weeks
Secondary Lesion count- non-inflammatory Percent change of acne lesion count from baseline at each evaluation visit 6 weeks
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