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Comparison Study of Topical Acne Regimens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913185
First Posted: June 4, 2009
Last Update Posted: June 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle Pelle, M.D., MedDerm Associates
  Purpose
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.

Condition Intervention Phase
Acne Drug: Acne Free, Proactiv Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Michelle Pelle, M.D., MedDerm Associates:

Estimated Enrollment: 128
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913185


Locations
United States, California
MedDerm Associates
San Diego, California, United States, 92103
Sponsors and Collaborators
MedDerm Associates
Investigators
Principal Investigator: Michelle T Pelle, M.D. Medical Director
  More Information

Additional Information:
Responsible Party: Michelle Pelle, M.D., Principal Investigator, MedDerm Associates
ClinicalTrials.gov Identifier: NCT00913185     History of Changes
Obsolete Identifiers: NCT00419523
Other Study ID Numbers: 1021
First Submitted: March 1, 2007
First Posted: June 4, 2009
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Michelle Pelle, M.D., MedDerm Associates:
Acne

Additional relevant MeSH terms:
Benzoyl Peroxide
Dermatologic Agents