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

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.
 
ClinicalTrials.gov Identifier: NCT00695578
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Biafine Drug: Polysporin Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover 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
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : February 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.

Drug: Polysporin
over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
Other Name: Bacitracin
Experimental: 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.
 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.

Drug: Polysporin
over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
Other Name: Bacitracin


Outcome Measures
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Primary Outcome Measures :
  1. Mean Severity Score [ Time Frame: 4 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
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United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Steve Feldman, MD, PhD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00695578    
Other Study ID Numbers: IRB00000341
31335 ( Other Identifier: WakeForest )
First Posted: June 12, 2008    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: December 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
 Bacitracin
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents