Actinic Keratosis Clinical Trial
Official title:
A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2008 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Severity Score | The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe | 4 weeks |
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