Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy

Wake Forest University20 enrolled

Overview

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.

Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Actinic Keratosis

Interventions

BiafineDRUG

Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

PolysporinDRUG

over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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