NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy | Biotech Hunter

Enrollment

166

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

September 30, 2016

Conditions

Actinic Keratosis

Interventions

DRUG

Aminolevulinic Acid

20% ALA applied to face for one hour prior to 10 J/cm2 blue light

DRUG

Topical Solution Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light

DEVICE

BLU-U

10 J/cm2 blue light delivered at 10 mW/cm2

PROCEDURE

Cryotherapy

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Trial Locations (8)

Sadick Research Group, New York

Virginia Clinical Research, Inc., Norfolk

Tennessee Clinical Research Center, Nashville

Shideler Clinical Research Center, Carmel

Altman Dermatology Associates, Arlington Heights

Suzanne Bruce and Associates, P.A.,The Center for Skin Research, Houston

UCSD Dermatology, San Diego

Therapeutics Clinical Research, San Diego