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Comparison Study of Topical Acne Regimens

This study is currently recruiting participants.
Verified by University Medical Products, January 2007

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 8 weeks of daily use.


Condition Intervention Phase
Acne
Drug: Acne Free
Drug: Proactiv
Phase IV

MedlinePlus related topics:   Acne   

U.S. FDA Resources

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

Further study details as provided by University Medical Products:

Estimated Enrollment:   128
Study Start Date:   November 2006

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.

  Eligibility
Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419523

Contacts
Contact: Melody L Cabardo     6192437015     mcabardo@medderm.net    

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

Sponsors and Collaborators
University Medical Products

Investigators
Principal Investigator:     Michelle T Pelle, M.D.     MedDerm Associates    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   MD-1021
First Received:   January 4, 2007
Last Updated:   January 4, 2007
ClinicalTrials.gov Identifier:   NCT00419523
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Exanthema
Facial Dermatoses
Facies
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:
Acneiform Eruptions

ClinicalTrials.gov processed this record on September 23, 2008




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