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Infrared Non-Cutting Laser Therapy for Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CoolTouch II laser
Sponsored by
University of Michigan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, laser

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Dermatology Department

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total area of sebum droplets measured using image analysis software

Full Information

First Posted
May 11, 2005
Last Updated
April 30, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00110643
Brief Title
Infrared Non-Cutting Laser Therapy for Acne
Official Title
CoolTouch Non-ablative Laser Therapy for Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CoolTouch II laser
Primary Outcome Measure Information:
Title
Number of subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones
Secondary Outcome Measure Information:
Title
total area of sebum droplets measured using image analysis software

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Voorhees, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Dermatology Department
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0314
Country
United States

12. IPD Sharing Statement

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Infrared Non-Cutting Laser Therapy for Acne

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