Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Study Overview
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Brief Summary
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Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.

Detailed Description
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Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows: Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2 A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.

Official Title
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Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Device: Alexandrite Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement. Exclusion Criteria: Pregnant patients or patients planning to get pregnant during the time of the study Patients on systemic treatment for Hidradenitis Suppurativa Patients with photosensitivity disorders Patients unable to tolerate the laser treatments Intake of a photosensitive medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For each patient, one side of the body will serve as the treatment side and the other side as the control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control | Device: Alexandrite Laser<br>* Alexandrite 755nm hair removal laser<br>|
| No Intervention: Control Arm<br>For each patient, one side of the body will be treated with the Alexandrite laser (the treatment arm) and the other will not be treated to serve as control (the control arm). For example, if a patient has the disease in both axillae, one will treatment and the other control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HS-LASI | Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline | Monthly for 4 months, then once 2 months later(6 months total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HiSCR | Change in Hidradenitis Suppurativa Clinical Response Scale from baseline | Monthly for 4 months, then once 2 months later(6 months total) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hidradenitis suppurativa, hidradenitis, laser