Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2017

Primary Completion Date

September 30, 2017

Study Completion Date

January 31, 2018

Conditions
Actinic Keratosis
Interventions
DRUG

ALA

20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light

DRUG

Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light

DEVICE

IBL 20 mW

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

DEVICE

IBL 10 mW

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

Trial Locations (7)

23507

Virginia Clinical Research, Inc., Norfolk

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

78759

DermResearch, Inc., Austin

92123

Therapeutics Clinical Research, San Diego

Sponsors
All Listed Sponsors
lead

DUSA Pharmaceuticals, Inc.

INDUSTRY