Back to resultsNon-cutting Laser Therapy in the Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
V-Beam laser, Candela Corp., 595 nm wavelength
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring non-ablative laser, acne, photosensitizer, photodynamic therapy
Eligibility Criteria
Inclusion Criteria: Age 15 years or older of either gender and of any racial/ethnic group. Presence of clinically-evident facial acne. 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 6 months 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 2 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 "exfoliating" 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 (excessive scar) formation for subjects undergoing biopsies. Pregnant or nursing females. Subjects with known allergy or hypersensitivity to topical photosensitizing agents. Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
Sites / Locations
- University of Michigan Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Laser Therapy
Control
Arm Description
V-Beam laser, Candela Corp., 595 nm wavelength
Untreated
Outcomes
Primary Outcome Measures
Change From Baseline in Papule Acne Lesions at Week 10
Change From Baseline in Pustule Acne Lesions at Week 10
Change From Baseline in Cysts at Week 10
Change From Baseline in Closed Comedones at Week 10
Change From Baseline in Open Comedones at Week 10
Change From Baseline in Erythematous Macules at Week 10
Change From Baseline in Acne Severity at Week 10
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Secondary Outcome Measures
Change From Baseline in Papule Acne Lesions at Week 16
Change From Baseline in Pustule Acne Lesions at Week 16
Change From Baseline in Cysts at Week 16
Change From Baseline in Closed Comedones at Week 16
Change From Baseline in Open Comedones at Week 16
Change From Baseline in Erythematous Macules at Week 16
Change From Baseline in Acne Severity at Week 16
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00113425
Brief Title
Non-cutting Laser Therapy in the Treatment of Acne
Official Title
Photodynamic Therapy in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
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. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. 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, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.
Detailed Description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
non-ablative laser, acne, photosensitizer, photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser Therapy
Arm Type
Experimental
Arm Description
V-Beam laser, Candela Corp., 595 nm wavelength
Arm Title
Control
Arm Type
No Intervention
Arm Description
Untreated
Intervention Type
Device
Intervention Name(s)
V-Beam laser, Candela Corp., 595 nm wavelength
Intervention Description
Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
Primary Outcome Measure Information:
Title
Change From Baseline in Papule Acne Lesions at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Pustule Acne Lesions at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Cysts at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Closed Comedones at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Open Comedones at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Erythematous Macules at Week 10
Time Frame
Baseline and Week 10
Title
Change From Baseline in Acne Severity at Week 10
Description
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Time Frame
Baseline and Week 10
Secondary Outcome Measure Information:
Title
Change From Baseline in Papule Acne Lesions at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Pustule Acne Lesions at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Cysts at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Closed Comedones at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Open Comedones at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Erythematous Macules at Week 16
Time Frame
Baseline and Week 16
Title
Change From Baseline in Acne Severity at Week 16
Description
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Time Frame
Baseline and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 15 years or older of either gender and of any racial/ethnic group.
Presence of clinically-evident facial acne.
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 6 months 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 2 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 "exfoliating" 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 (excessive scar) formation for subjects undergoing biopsies.
Pregnant or nursing females.
Subjects with known allergy or hypersensitivity to topical photosensitizing agents.
Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
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 Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-cutting Laser Therapy in the Treatment of Acne
We'll reach out to this number within 24 hrs