Comparison Study of Topical Acne Regimens

June 23, 2014 updated by: Michelle Pelle, M.D., MedDerm Associates

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

You will receive a study drug for the 8 week study. No subject will be given a placebo (an inactive substance) during treatment.The study drugs (over the counter acne medications) have been previously tested and their safe use has been established. However, not all risks or side effects are known. In rare cases of allergy, side effects may be life threatening.The most common side effects of this study drug are:

  1. Dry skin
  2. Peeling skin
  3. Red skin
  4. Burning or tingling (temporary)

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • MedDerm Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedDerm Associates

Investigators

  • Principal Investigator: Michelle T Pelle, M.D., Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne

Clinical Trials on Acne Free, Proactiv

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe