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| Sponsor: | University of Michigan |
|---|---|
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00113425 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Device: V-Beam laser, Candela Corp., 595 nm wavelength |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Photodynamic Therapy in the Treatment of Acne Vulgaris |
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan Department of Dermatology | |
| Ann Arbor, Michigan, United States, 48109 | |
| Study Chair: | John J Voorhees, MD | University of Michigan |
More Information
| Responsible Party: | Jeffrey Orringer, MD, Clinical Assistant Professor, University of Michigan Department of Dermatology |
| ClinicalTrials.gov Identifier: | NCT00113425 History of Changes |
| Other Study ID Numbers: | Derm 548 |
| Study First Received: | June 7, 2005 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
non-ablative laser acne photosensitizer photodynamic therapy |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |