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

This study has been completed.
Sponsor:
Collaborator:
Ikeno Clinic
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00714454
First received: July 3, 2008
Last updated: July 11, 2008
Last verified: July 2008
  Purpose

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 Intervention
Acne Vulgaris
Other: APS Topical Lotion
Other: Placebo

Study Type: Interventional
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 NLM:


Further study details as provided by University of Miami:

Arms Assigned Interventions
Active Comparator: APS Other: APS Topical Lotion
Placebo Comparator: Vehicle Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714454

Locations
United States, Florida
University of Miami Cosmetic Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
University of Miami
Ikeno Clinic
Investigators
Principal Investigator: Heather Woolery-Lloyd, MD University of Miami
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00714454     History of Changes
Other Study ID Numbers: 97269358-APS
Study First Received: July 3, 2008
Last Updated: July 11, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Ascorbate-2-phosphate
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014