Condition(s) treated: Acne

Intervention: Acne Free (Drug); Proactiv (Drug)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: University Medical Products

Principal investigator(s) or official(s):
Michelle T Pelle, M.D., Principal Investigator, Affiliation: MedDerm Associates

Overall contact:
Melody L Cabardo, Phone: 6192437015, Email: mcabardo@medderm.net

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 8 weeks of daily use.

Official title: Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: 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.

Minimum eligible age: 13 Years. Maximum eligible age: 45 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject and/or legal guardian of the subject willing to sign an Informed Consent Form,

Assent Form if indicated, and a HIPAA Authorization Form.

- Subjects who have received the permission of a parent or guardian to participate in

this study or cannot be classified as a minor, under the age of 18 years.

- Male and female subjects between the ages of 13 and 45 years and in generally good

health, as determined by a Medical History Form.

- Subjects with moderately-severe acne vulgaris of the face and neck as determined and

defined by baseline lesion counts (see Definition: Acne Severity above).

- Subjects who have completed a Medical History Form .

- Subjects who have not used oral acne medications for 1 month prior to start of study,

and topical acne medications 1 week prior to start of study.

- Subjects who agree not to use any acne medication during the study except for the test

materials given to them.

- Subjects who agree not to use any make-up that contains acne treatment additives, such

as benzoyl peroxide, salicylic acid or retinol.

- Subjects who are willing to be photographed and video-recorded during study visits and

willing to sign photographic release forms.

- Subjects who exhibit dependability and intelligence in following directions.

Exclusion Criteria:

- Subjects who are pregnant or lactating.

- Subjects with known allergies to cosmetic, toiletry, or acne treatment products.

- Subjects who are sensitive to any of the ingredients in the test articles.

- Subjects who have participated in a facial treatment study within 3 weeks of study

initiation.

- Subjects exhibiting acute or chronic dermatological, medical, and/or physical

conditions which would preclude application of the test materials and/or influence the outcome of the study.

- Subjects who are unwilling to sit quietly for 15 minutes to acclimate to ambient

temperature and humidity conditions in the laboratory.

- Male subjects who do not have a full beard.

- Subjects who cannot stop usage of oral acne mediation 1 month prior to study start,

and topical acne medications 1 week prior to study start.

- Subjects taking routine high dosage anti-inflammatory medications (aspirin,

ibuprofen).

- Use of corticosteroids, immunosuppressive drugs or antihistamine medications (steroid

inhalers or decongestant nose drops and/or eye drops are permitted).

- Any condition for which the Investigator determines that the subject could be placed

under undo risk.

Melody L Cabardo, Phone: 6192437015, Email: mcabardo@medderm.net

MedDerm Associates, San Diego, California 92103, United States; Recruiting

Start date: November 2006
Last updated: January 4, 2007

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