5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
NCT ID: NCT00714454
Last Updated: 2008-07-14
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
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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APS
APS Topical Lotion
Vehicle
Placebo
Interventions
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APS Topical Lotion
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subject has visible mild to severe acne, as assessed by the investigator.
* Subject will be available and willing to return for follow-up visits.
* Subject agrees not to use any other acne treatment products during the study.
* Subject is otherwise healthy, non-febrile, and is not suffering from an infection likely to require antibiotic therapy during the study period.
* Subject or guardian must be able to understand the new HIPAA regulations and sign the HIPAA form.
* Subject is between the ages of 18 and 39.
* Subject agrees and understands that APS or its vehicle is to be applied to the subject twice daily for 12 weeks; no other topical or systemic medication affecting the course of acne and/or evaluability is to be used during the study.
* Subject agrees to use only the cleanser, moisturizer with sunscreen, and treatment provided by the study site for the duration of the study.
* Subject understands and agrees that he/she can not be treated with a systemic antibiotic for acne during the study.
* Subject agrees he/she will not use an acne topical treatment for two weeks prior to Day 0.
Exclusion Criteria
* Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment which in the opinion of the investigator could influence the results of the study.
* Subject is pregnant or lactating.
* Subject is suffering from an abnormal skin condition not usually associated with acne.
* Subject will not be available for follow-up visits.
* Subject has been previously enrolled in any clinical study in which treatment was received within the past 30 days.
* Subjects without comedones, papules, pustules, or nodules.
* Subject has a history of hypersensitivity to any other ingredients of the study lotion.
* Subject has a history of anaphylaxis.
* Subject is not able to avoid excessive sun exposure.
18 Years
39 Years
ALL
Yes
Sponsors
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Ikeno Clinic
UNKNOWN
University of Miami
OTHER
Principal Investigators
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Heather Woolery-Lloyd, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Cosmetic Center
Miami Beach, Florida, United States
Countries
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Other Identifiers
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97269358-APS
Identifier Type: -
Identifier Source: org_study_id