Comparison Study of Topical Acne Regimens

NCT00913185 | Completed Phase 4 DMC

• 1 other identifier: 1021
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of two over the counter acne products in subjects with moderate severity acne vulgaris. The two products being compared in this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and Proactiv® manufactured by Guthy-Renker.

Conditions

Acne

Keywords

Acne

Interventions

Acne Free, Proactiv DRUG

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects and/or subjects' legal guardians who understand and are willing to sign an Informed Consent Form, an 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.

You may not qualify if:

• 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 unable 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).
• Subjects who must use oral corticosteroids and/or oral immunosuppressive drugs (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.

Sponsors & Collaborators

• MedDerm Associates: lead

Study Sites (1)

MedDerm Associates

San Diego, California, 92103, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Michelle T Pelle, M.D.

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: June 4, 2009
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)