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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106807
• Other study ID #: RD.06.SPR.18173
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

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