Photodynamic Therapy in the Treatment of Acne

NCT00613444 | Withdrawn

• 2 other identifiers: Derm 590HUM00016677
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Acne; laser

Outcome Measures

Primary Outcomes (1)

• Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones. In addition to lesion counts, overall acne severity will be graded by the investigator using the Leeds acne severity scale.

  Baseline and follow-up evaluations

Secondary Outcomes (2)

• Sebum production

  Baseline and follow-up evaluations

• Photographs

  Baseline and follow-up evaluations

Study Arms (1)

LumaCare LC-122M non-coherent light source

EXPERIMENTAL

Split Face Comparison. One half of subject's face will receive topical photosensitizer applications followed by LumaCare LC-122M non-coherent light source illumination. 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. The other half of the face will not receive any treatment and will serve as internal control.

Device: LumaCare LC-122M non-coherent light source

Interventions

LumaCare LC-122M non-coherent light source DEVICE

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.

LumaCare LC-122M non-coherent light source

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15 years or older of either gender and of any racial/ethnic group.
• Presence of clinically-evident facial acne.
• Subjects must be in generally good health.
• Subjects must be able and willing to comply with the requirements of the protocol.
• Subjects must have Fitzpatrick skin type I, II or III.
• You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

You may not qualify if:

• Oral retinoid use within six months of entry into the study.
• Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
• Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
• Microdermabrasion or superficial chemical peels at the sites to be treated within 2 months of entry into the study.
• Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
• Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
• Non-compliant subjects.
• Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
• Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
• Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
• History of keloid scar formation for subjects undergoing biopsies.
• Pregnant or nursing females.
• Subjects with known allergy or hypersensitivity to topical photosensitizing agents.
• Subjects with Fitzpatrick skin type IV or greater.
• Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Medical School

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2010
• Last Updated: May 4, 2015

Record last verified: 2015-04