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Infrared Non-Cutting Laser Therapy for Acne

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00110643
First received: May 11, 2005
Last updated: August 6, 2008
Last verified: August 2008
History of Changes
  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. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.


Condition Intervention Phase
Acne Vulgaris
 Device: CoolTouch II laser
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: CoolTouch Non-Ablative Laser Therapy for Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

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

Secondary Outcome Measures:
  • Sebum production will be measured with Sebutape
  • Photographic evaluations

Estimated Enrollment: 50
Study Start Date: February 2003
Estimated Study Completion Date: December 2005
Detailed Description:

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 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. 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. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 13 years or older of either gender and of any racial/ethnic group.
  • Subjects must have clinically evident acne vulgaris of the facial skin.
  • Subjects must understand and sign the informed consent prior to participation.
  • 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 1 year 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 3 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 scar formation for subjects undergoing biopsies.
  • Pregnant or nursing females.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110643

Locations
United States, Michigan
University of Michigan Dermatology Department
Ann Arbor, Michigan, United States, 48109-0314
Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: John J Voorhees, MD University of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00110643     History of Changes
Other Study ID Numbers: Derm 494
Study First Received: May 11, 2005
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Acne
laser

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

ClinicalTrials.gov processed this record on May 16, 2013