Phase 4
Completed N=20
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Source: ClinicalTrials.gov NCT00695578 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Mean Severity Score — -1.52; -1.80 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Severity Score |
-1.52; -1.80 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00695578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.