NCT03054155

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DEVICE	Alexandrite Laser	Alexandrite 755nm hair removal laser

Timeline

• Start date: 2017-05-11
• Primary completion: 2022-09-01
• Completion: 2022-10-31
• First posted: 2017-02-15
• Last updated: 2023-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study