Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

PHASE3CompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Actinic Keratosis
Interventions
DRUG

Aminolevulinic Acid (ALA)

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

DRUG

Topical Solution Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

DEVICE

Blue Light Photodynamic Therapy Illuminator (BLU-U)

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

Trial Locations (13)

23507

Virginia Clinical Research, Inc., Norfolk

33180

Center for Clinical and Cosmetic Research, Aventura

33609

MOORE Clinical Research, Inc, Brandon

33716

Spencer Clinical Services, St. Petersburg

46032

Shideler Clinical Research Center, Carmel

46168

The Indiana Clinical Trials Center, PC, Plainfield

55432

Minnesota Clinical Study Center, Fridley

60005

Altman Dermatology Associates, Arlington Heights

77056

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

77845

J&S Studies, Inc, College Station

92122

UCSD Dermatology, San Diego

94538

Center For Dermatology Clinical Research, Inc., Fremont

97210

Oregon Dermatology and Research Center, Portland

Sponsors
All Listed Sponsors
lead

DUSA Pharmaceuticals, Inc.

INDUSTRY