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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695578
• Other study ID #: IRB00000341
• Secondary ID: 31335
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Biafine
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.
• Polysporin
over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

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