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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

May 11, 2005
August 6, 2008
February 2003
Not Provided
Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones
Same as current
Complete list of historical versions of study NCT00110643 on ClinicalTrials.gov Archive Site
  • Sebum production will be measured with Sebutape
  • Photographic evaluations
Same as current
Not Provided
Not Provided
 
Infrared Non-Cutting Laser Therapy for Acne
CoolTouch Non-Ablative Laser Therapy for Acne Vulgaris

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Acne Vulgaris
Device: CoolTouch II laser
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2005
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110643
Derm 494
Not Provided
Not Provided
University of Michigan
Not Provided
Study Chair: John J Voorhees, MD University of Michigan
University of Michigan
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP