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-sensitiser (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitiser 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-sensitiser actually enhances the efficacy of the laser.

Official Title

Photodynamic Therapy in the Treatment of Acne Vulgaris.

Conditions

  • Acne Vulgaris

Study Type

Interventional

Study Design

Treatment, Randomised, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

  • Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones
    [Time Frame: These outcomes will be measured at follow-up evaluation visits during the treatment series, and up to every four weeks following the final treatment for a total of up to 12 weeks.][Designated as safety issue: No]

Secondary Outcome Measures:

  • Cutaneous sebum production (optional)
    [Time Frame: Sebum production will be measured at baseline, at follow-up evaluation visits during the treatment series, and up to every four weeks following the final laser treatment for a total of up to 12 weeks.]
    [Designated as safety issue: No]

Study Start

August 2005

Eligibility & Criteria

  • Ages Eligible for Study: 15 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • 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.
  • 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 Criteria:

  • Oral retinoid (Accutane) use within 6 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 "exfolliating" 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 (excessive scar) formation for subjects undergoing biopsies.
  • Pregnant or nursing females.
  • Subjects with known allergy or hypersensitivity to topical photosensitising agents.
  • Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.

Total Enrolment

75

Contact Details

University of Michigan Department of Dermatology   
Ann Arbor, Michigan
United States, 48109