Infrared Non-Cutting Laser Therapy for Acne

Acne Vulgaris Clinical Trial

Official title:

CoolTouch Non-ablative Laser Therapy for Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110643
• Other study ID #: Derm 494
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 11, 2005
• Last updated: April 30, 2015
• Start date: February 2003
• Est. completion date: December 2005

Study information

• Verified date: April 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• CoolTouch II laser

Locations

Country	Name	City	State
United States	University of Michigan Dermatology Department	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones
Secondary	total area of sebum droplets measured using image analysis software