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Photodynamic Therapy in the Treatment of Acne

NCT00613444 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-04

No results posted yet for this study

Summary

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.

The photo-sensitizing agent (Levulan Kerastick) and the non-ablative laser (LumaCare LC-122M non-coherent (multiple wavelengths) light source from LumaCare® Medical Products) are both FDA-approved. The Levulan Kerastick is approved for the treatment of another skin disease, not acne.

Conditions

  • Acne Vulgaris

Interventions

DEVICE

LumaCare LC-122M non-coherent light source

Subjects will receive a series of up to 6 treatment sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, light treatment parameters will be within the guidelines normally used clinically for red-light non-coherrent light sources, and thus fluences used will not exceed 75 J/cm2.

Sponsors & Collaborators

Principal Investigators

  • John J Voorhees, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-02-29
Completion
2010-03-31

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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 NCT00613444 on ClinicalTrials.gov