A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Phase 4
50 Years
N/A
50 Years
N/A
Not Enrolling
Both
Actinic Keratosis
Both
Actinic Keratosis
Trial Information
A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Inclusion Criteria:
- Subject must give written consent.
- Subjects must be >50 years of age, male or female.
- Subjects must have had cryotherapy treatment of at least one AK's on each forearm in
the Dermatology Clinic.
Exclusion Criteria:
- Subjects age <50 years of age.
- Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for AK while
participating in the study.
- Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid
products, retinoids and chemical peel agents in the treatment areas while on study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
The change of the target lesions from Baseline to or end of treatment in the IGA
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
Steve Feldman, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
00000341
NCT ID:
NCT00695578
Start Date:
October 2006
Completion Date:
February 2008
Related Keywords:
- Actinic Keratosis
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Wake Forest University Health Sciences Dermatology | Winston Salem, North Carolina 27157 |
