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

NCT ID: NCT00695578

Last Updated: 2018-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Biafin on left arm

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

Group Type EXPERIMENTAL

Biafine

Intervention Type DRUG

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

Intervention Type DRUG

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

Biafin on right arm

Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Group Type EXPERIMENTAL

Biafine

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Polysporin

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

Intervention Type DRUG

Other Intervention Names

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Bacitracin

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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31335

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00000341

Identifier Type: -

Identifier Source: org_study_id