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 )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Actinic Keratosis
• Interventions: Drug: Biafine; Drug: Polysporin
• Enrollment: 20

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Biafin on Left	Biafin on Right
Arm/Group Description	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. 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. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds	Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) 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. 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. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
Period Title: Overall Study
Started	10	10
Completed	10	10
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Biafin on Left	Biafin on Right	Total
Arm/Group Description		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. 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. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds	Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) 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. 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. Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds	Total of all reporting groups
Overall Number of Baseline Participants		10	10	20
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants	10 participants	20 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	2 20.0%	3 30.0%	5 25.0%
	>=65 years	8 80.0%	7 70.0%	15 75.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants	10 participants	20 participants
	Female	1 10.0%	0 0.0%	1 5.0%
	Male	9 90.0%	10 100.0%	19 95.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants	10 participants	20 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	10 100.0%	10 100.0%	20 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	10 participants	10 participants	20 participants
		10	10	20

Outcome Measures

1. Primary Outcome

Title	Mean Severity Score
Description	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
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biafine Treatment Group	Polysporin Treatment Group
Arm/Group Description:	This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was 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. Other Names: • Biafine	This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds Other Names: • Bacitracin
Overall Number of Participants Analyzed	20	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.52 (0.67)	-1.80 (1.44)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Biafin Treatment Group	Polysporin Treatment Group
Arm/Group Description	Experimental: Biafine Treatment Group This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was 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. Other Names: • Biafine	Active Comparator: Polysporin Treatment Group This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds Other Names: • Bacitracin
All-Cause Mortality
	Biafin Treatment Group	Polysporin Treatment Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)
Serious Adverse Events
	Biafin Treatment Group	Polysporin Treatment Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Biafin Treatment Group	Polysporin Treatment Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Steve Feldman MD
• Organization: Wake Forest University Health Sciences
• Phone: 336-716-3775
• EMail: sfeldman@wakehealth.edu

• Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
• ClinicalTrials.gov Identifier: NCT00695578
• Other Study ID Numbers: IRB00000341; 31335 ( Other Identifier: WakeForest )
• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Results First Submitted: February 6, 2017
• Results First Posted: December 31, 2018
• Last Update Posted: December 31, 2018