Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/2/2019 |
| Start Date: | October 2006 |
| End Date: | February 2008 |
A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
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.
by removal of actinic keratosis using cryotherapy in a clinical setting.
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.
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.
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.
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