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

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00695578
First received: June 9, 2008
Last updated: February 12, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

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:
    Drug: Biafine
    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.
    Other Name: Biafine
  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 School of Medicine
Investigators
Principal Investigator: Steve Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

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

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014