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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Actinic Keratosis

Treatments: Drug: Polysporin; Drug: Biafine

Study type: Interventional

Funder types: Other

Identifiers

NCT00695578

IRB00000341

31335 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Biafin on left arm

Experimental 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.

Treatment:

Drug: Biafine

Drug: Polysporin

Biafin on right arm

Experimental group

Description:

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.

Treatment:

Drug: Biafine

Drug: Polysporin