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| Sponsored by: |
University Medical Products |
|---|---|
| Information provided by: | University Medical Products |
| ClinicalTrials.gov Identifier: | NCT00419523 |
Purpose
This study will compare the effectiveness of the two acne treatment regimens, Acne Free and Proactiv, for the treatment of moderately severe acne vulgaris of the face and neck. It will also compare the irritancy of each regimen over 12 weeks of daily use.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne |
Drug: Acne Free Drug: Proactiv |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris |
| Estimated Enrollment: | 128 |
| Study Start Date: | November 2006 |
| Study Completion Date: | February 2008 |
Acne vulgaris is an inflammatory disorder of the pilosebaceous units. It affects approximately 85 percent of adolescents and young adults. Acne lesions occur on the face, but may affect the nonfacial sites such as the chest, back and shoulders. Acne lesions are divided into two types: non-inflammatory (open and closed comedones) and inflammatory lesions (papules, pustules, nodules and inflammatory cysts). Subjects will be randomized into one of two groups. Each subject will be given an acne regimen to take home and use for 8 weeks. The following data measurements will be performed on each subject at each of 4 study visits: I. Investigator Assessment of Acne Lesion Counts (Quantitative Assessment),II. Investigator Global Assessment of Acne Severity (Qualitative Assessment),III. Investigator Visual Assessment of Irritation and Scaling. Subjects will also fill out a diary and answer a questionnaire at each visit.
Eligibility| Ages Eligible for Study: | 13 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| MedDerm Associates | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Michelle T Pelle, M.D. | MedDerm Associates |
More Information
| Study ID Numbers: | MD-1021 |
| Study First Received: | January 4, 2007 |
| Last Updated: | June 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00419523 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Exanthema Facial Dermatoses Facies |
Skin Diseases Sebaceous Gland Diseases Acne Vulgaris |
|
Facial Dermatoses Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Acne Vulgaris |