5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714454
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
Ikeno Clinic
Information provided by:
University of Miami

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: APS Topical Lotion Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Official Title: 5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris: A Double-Blind, Placebo Controlled Trial

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: APS Other: APS Topical Lotion
Placebo Comparator: Vehicle Other: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714454

United States, Florida
University of Miami Cosmetic Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
University of Miami
Ikeno Clinic
Principal Investigator: Heather Woolery-Lloyd, MD University of Miami Identifier: NCT00714454     History of Changes
Other Study ID Numbers: 97269358-APS
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: July 14, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Antineoplastic Agents