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

This study has been completed.

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00695578

Purpose

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.

Condition	Intervention	Phase
Actinic Keratosis	Drug: Biafine	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Investigator), Single Group Assignment, Efficacy Study
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

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

The change of the target lesions from Baseline to or end of treatment in the IGA [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	October 2006
Study Completion Date:	February 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695578

Locations

United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Steve Feldman, MD, PhD

Wake Forest University

More Information

No publications provided

Responsible Party:	Wake Forest University Health Sciences ( Steve Feldman, MD PhD )
Study ID Numbers:	00000341, 31335
Study First Received:	June 9, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00695578
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Keratosis
Alginic acid
Skin Diseases
Mineral Oil
Tylosis

ClinicalTrials.gov processed this record on February 12, 2009