Non-cutting Laser Therapy in the Treatment of Acne

Study Overview
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Brief Summary
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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
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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.

Official Title
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Photodynamic Therapy in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: V-Beam laser, Candela Corp., 595 nm wavelength


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Therapy<br>V-Beam laser, Candela Corp., 595 nm wavelength | Device: V-Beam laser, Candela Corp., 595 nm wavelength<br>* 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.<br>|
| No Intervention: Control<br>Untreated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Papule Acne Lesions at Week 10 |  | Baseline and Week 10 | 
| Change From Baseline in Pustule Acne Lesions at Week 10 |  | Baseline and Week 10 | 
| Change From Baseline in Cysts at Week 10 |  | Baseline and Week 10 | 
| Change From Baseline in Closed Comedones at Week 10 |  | Baseline and Week 10 | 
| Change From Baseline in Open Comedones at Week 10 |  | Baseline and Week 10 | 
| Change From Baseline in Erythematous Macules at Week 10 |  | Baseline and 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. | Baseline and Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Papule Acne Lesions at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Pustule Acne Lesions at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Cysts at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Closed Comedones at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Open Comedones at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Erythematous Macules at Week 16 |  | Baseline and 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. | Baseline and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, non-ablative laser, photosensitizer, photodynamic therapy