Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2006-12-31
2008-02-29
Brief Summary
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Detailed Description
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1. Dry skin
2. Peeling skin
3. Red skin
4. Burning or tingling (temporary)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Acne Free, Proactiv
Eligibility Criteria
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Inclusion Criteria
* 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 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.
13 Years
45 Years
ALL
Yes
Sponsors
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MedDerm Associates
INDUSTRY
Responsible Party
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Michelle Pelle, M.D.
Principal Investigator
Principal Investigators
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Michelle T Pelle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical Director
Locations
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MedDerm Associates
San Diego, California, United States
Countries
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Related Links
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Related Info
Other Identifiers
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1021
Identifier Type: -
Identifier Source: org_study_id
NCT00419523
Identifier Type: -
Identifier Source: nct_alias
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