Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

PHASE2CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

September 12, 2016

Study Completion Date

September 12, 2016

Conditions
Actinic Keratosis
Interventions
DRUG

ALA

20% ALA applied to face prior to light treatment

DRUG

Topical Solution Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment

DEVICE

IBL 10 mW

10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds

PROCEDURE

Microneedle lesion preparation

Microneedling of all visible/palpable AK lesions prior to solution application.

DEVICE

IBL 20 mW

10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds

Trial Locations (8)

23507

Virginia Clinical Research, Inc., Norfolk

33609

MOORE Clinical Research, Inc, Brandon

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

92122

UCSD Dermatology, San Diego

92123

Therapeutics Clinical Research, San Diego

Sponsors
All Listed Sponsors
lead

DUSA Pharmaceuticals, Inc.

INDUSTRY