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Clinical trial

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

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Last updated:26th May 2020
Status: Recruiting
Identifier: NCT03054155
Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Brief Summary:
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:
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.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
Actual Study Start Date: May 11, 2017
Estimated Primary Completion Date: October 31, 2021
Estimated Study Completion Date: October 31, 2021

- Experimental: Treatment Arm
- No Intervention: Control Arm

Category Value
Study type(s) Interventional
Estimated enrolment 20
Actual Study start date 11 May 2017
Estimated Study Completion Date 31 October 2021

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