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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695578
First Posted: June 12, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wake Forest University Health Sciences
  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: Intervention Model: Single Group Assignment
Masking: Single (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 University Health Sciences:

Primary Outcome Measures:
  • The change of the target lesions from Baseline to or end of treatment in the IGA [ Time Frame: 4 weeks ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Health Sciences
  More Information

Responsible Party: Steve Feldman, MD PhD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00695578     History of Changes
Other Study ID Numbers: 00000341
31335
First Submitted: June 9, 2008
First Posted: June 12, 2008
Last Update Posted: October 12, 2017
Last Verified: February 2009

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