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Infrared Non-Cutting Laser Therapy for Acne

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110643
First Posted: May 12, 2005
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey S. Orringer, University of Michigan
  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: Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: CoolTouch Non-ablative Laser Therapy for Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Jeffrey S. Orringer, University of Michigan:

Primary Outcome Measures:
  • Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones

Secondary Outcome Measures:
  • total area of sebum droplets measured using image analysis software

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jeffrey S. Orringer, Professor of Dermatology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT00110643     History of Changes
Other Study ID Numbers: Derm 494
First Submitted: May 11, 2005
First Posted: May 12, 2005
Last Update Posted: May 4, 2015
Last Verified: April 2015

Keywords provided by Jeffrey S. Orringer, University of Michigan:
Acne
laser

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