Status:
WITHDRAWN
Photodynamic Therapy in the Treatment of Acne
Lead Sponsor:
University of Michigan
Conditions:
Acne Vulgaris
Eligibility:
All Genders
15+ years
Phase:
NA
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 l...
Detailed Description
Background 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 morb...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
- Subjects with Fitzpatrick skin type IV or greater.
- Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00613444
Start Date
February 1 2008
End Date
March 1 2010
Last Update
May 4 2015
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