MedTrace Logo

Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

NCT01475955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2016-10-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Broad Area ALA 1-hour incubation

20% ALA, broad area, 1 hour incubation

DRUG

Broad Area ALA 2 hour incubation

20% ALA broad area 2-hour incubation

DRUG

broad area ALA 3-hour incubation

20% ALA broad area 3 hour incubation

DRUG

Spot ALA 2 hour incubation

20% ALA spot 2 hour incubation

DRUG

Vehicle PDT

Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

DEVICE

Blue Light Treatment

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

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Marcus, MD, PhD · DUSA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475955 on ClinicalTrials.gov