Infrared Non-Cutting Laser Therapy for Acne

NCT00110643 | Completed Phase 2

• 1 other identifier: Derm 494
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

Acne; laser

Outcome Measures

Primary Outcomes (1)

• Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones

Secondary Outcomes (1)

• total area of sebum droplets measured using image analysis software

Interventions

CoolTouch II laser DEVICE

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Dermatology Department

Ann Arbor, Michigan, 48109-0314, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Medical School

Study Record Dates

• First Submitted: May 11, 2005
• First Posted: May 12, 2005
• Study Start: February 1, 2003
• Study Completion: December 1, 2005
• Last Updated: May 4, 2015

Record last verified: 2015-04

Locations

US (1)