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

• 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: Wake Forest University
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information

• First Submitted Date: June 9, 2008
• First Posted Date: June 12, 2008
• Results First Submitted Date: February 6, 2017
• Results First Posted Date: December 31, 2018
• Last Update Posted Date: December 31, 2018
• Study Start Date: October 2006
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2018)

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

• Original Primary Outcome Measures (submitted: June 10, 2008): The change of the target lesions from Baseline to or end of treatment in the IGA [ Time Frame: 4 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Actinic Keratosis

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Drug: Biafine
  • Drug: Polysporin
• 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.
  Interventions:

  • Drug: Biafine
  • Drug: Polysporin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2008): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00695578
• Other Study ID Numbers: IRB00000341; 31335 ( Other Identifier: WakeForest )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
• Original Responsible Party: Steve Feldman, MD PhD, Wake Forest University Health Sciences
• Current Study Sponsor: Wake Forest University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Steve Feldman, MD, PhD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: July 2018