Non-cutting Laser Therapy in the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: V-Beam laser, Candela Corp., 595 nm wavelength
Intervention description: Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: non-ablative laser; acne; photosensitizer; photodynamic therapy

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.
    

Eligibility criteria:

        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 "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 (excessive 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.