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


Phase 4
50 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

The change of the target lesions from Baseline to or end of treatment in the IGA

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Steve Feldman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

00000341

NCT ID:

NCT00695578

Start Date:

October 2006

Completion Date:

February 2008

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Wake Forest University Health Sciences DermatologyWinston Salem, North Carolina  27157