Comparison Study of Topical Acne Regimens
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acne Free, Proactiv
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring Acne
Eligibility 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.
Sites / Locations
- MedDerm Associates
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913185
Brief Title
Comparison Study of Topical Acne Regimens
Official Title
Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MedDerm Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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:
Dry skin
Peeling skin
Red skin
Burning or tingling (temporary)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acne Free, Proactiv
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle T Pelle, M.D.
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedDerm Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Links:
URL
http://medderm.net
Description
Related Info
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Comparison Study of Topical Acne Regimens
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