Back to results5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APS Topical Lotion
Placebo
Sponsored by
About this trial
This is an interventional trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Subject has read, understood, and signed appropriate informed consent, photo consent, and HIPAA consent in their own language.
- 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 or guardian has not signed informed consent, photo consent or HIPAA form.
- 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.
Sites / Locations
- University of Miami Cosmetic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
APS
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00714454
First Posted
July 3, 2008
Last Updated
July 11, 2008
Sponsor
University of Miami
Collaborators
Ikeno Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00714454
Brief Title
5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
Official Title
5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris: A Double-Blind, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Miami
Collaborators
Ikeno Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
12-week study to compare the efficacy and safety of a course of a twice daily treatment with APS in the form of a lotion to its vehicle for the treatment of acne.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
APS
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
APS Topical Lotion
Intervention Type
Other
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject has read, understood, and signed appropriate informed consent, photo consent, and HIPAA consent in their own language.
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 or guardian has not signed informed consent, photo consent or HIPAA form.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Woolery-Lloyd, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Cosmetic Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
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