Infrared Non-Cutting Laser Therapy for Acne

NCT ID: NCT00110643

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-12-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

CoolTouch II laser

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey S. Orringer

Professor of Dermatology, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Voorhees, MD

Role: STUDY_CHAIR

University of Michigan

Locations

University of Michigan Dermatology Department

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 494

Identifier Type: -

Identifier Source: org_study_id