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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00695578
Other study ID # IRB00000341
Secondary ID 31335
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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 BiafineĀ® 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.

Study Design


Related Conditions & MeSH terms


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
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