Non-cutting Laser Therapy in the Treatment of Acne

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00113425
First received: June 7, 2005
Last updated: June 2, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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 to12 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 ]

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)
Intervention Details:
    Device: V-Beam laser, Candela Corp., 595 nm wavelength
    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.
Detailed Description:

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
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 "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 photosensitizing agents.
  • Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113425

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: John J Voorhees, MD University of Michigan
  More Information

No publications provided

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

Keywords provided by University of Michigan:
non-ablative laser
acne
photosensitizer
photodynamic therapy

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on August 28, 2014