NCT00695578

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

A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-06-01
• Completion: 2008-02-01
• First posted: 2008-06-12
• Last updated: 2018-12-31
• Results posted: 2018-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study