Infrared Non-Cutting Laser Therapy for Acne

Phase 2

Completed

• Conditions: Acne Vulgaris

• Registration Number: NCT00110643
• Lead Sponsor: University of Michigan

Brief 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. 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.

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-05-11
• Study First Submitted QC: 2005-05-11
• Study First Posted: 2005-05-12
• Study Completion: 2005-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones

Secondary Outcome Measures

Name	Time	Method
total area of sebum droplets measured using image analysis software

Trial Locations

Locations (1)

University of Michigan Dermatology Department; 🇺🇸 Ann Arbor, Michigan, United States