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

NCT00695578 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB0000034131335
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Mean Severity Score

  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

  4 weeks

Study Arms (2)

Biafin on left arm

EXPERIMENTAL

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; Drug: Polysporin

Biafin on right arm

EXPERIMENTAL

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; Drug: Polysporin

Interventions

Biafine DRUG

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.

Biafin on left arm; Biafin on right arm

Polysporin DRUG

over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Also known as: Bacitracin

Biafin on left arm; Biafin on right arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Biafine; bacitracin, polymyxin B drug combination; Bacitracin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Steve Feldman MD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Steve Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: February 1, 2008
• Last Updated: December 31, 2018
• Results First Posted: December 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)