Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03054155 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2017
Last Update Posted : May 27, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hidradenitis Suppurativa | Device: Alexandrite Laser | Not Applicable |
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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Arm
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
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Device: Alexandrite Laser
Alexandrite 755nm hair removal laser |
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No Intervention: Control Arm
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
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- HS-LASI [ Time Frame: Monthly for 4 months, then once 2 months later(6 months total) ]Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline
- HiSCR [ Time Frame: Monthly for 4 months, then once 2 months later(6 months total) ]Change in Hidradenitis Suppurativa Clinical Response Scale from baseline
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054155
| Contact: Steven D Daveluy, MD | 3134297854 | sdaveluy@med.wayne.edu | |
| Contact: Emma Reaves | 3134297845 | az3432@wayne.edu |
| United States, Michigan | |
| Wayne State University Physician Group Dermatology | Recruiting |
| Dearborn, Michigan, United States, 48124 | |
| Contact: Steven D Daveluy, MD 313-429-7854 sdaveluy@med.wayne.edu | |
| Contact: Emma Reaves 3134297845 az3432@wayne.edu | |
| Principal Investigator: Steven D Daveluy, MD | |
| Sub-Investigator: Rachel Ward, MD | |
| Sub-Investigator: Kristin Totoraitis, BS | |
| Responsible Party: | Steven D Daveluy, Medical Doctor, Wayne State University |
| ClinicalTrials.gov Identifier: | NCT03054155 |
| Other Study ID Numbers: |
120116M1F |
| First Posted: | February 15, 2017 Key Record Dates |
| Last Update Posted: | May 27, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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hidradenitis suppurativa hidradenitis laser |
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Skin Diseases, Infectious Infection Suppuration |