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The purpose of this study is to evaluate whether Alexandrite laser treatment is non-inferior to Nd:YAG (neodymium-doped yttrium aluminum garnet) laser treatment of hidradenitis suppurativa (HS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving treatment with both laser types | Experimental | Participants will receive split-body treatment, receiving Nd:YAG laser treatment to an affected anatomical site (axilla, inframammary region, or groin) and Alexandrite laser to the contralateral side. The treatment side will be randomized and maintained through the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nd:YAG Laser | Device | Nd:YAG laser applied to one side of the participant's body (e.g. left or right) according to randomization, every 4-6 weeks for 4 consecutive treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HiSCR50 | Percentage of patients achieving a 50% reduction in their hidradenitis suppurativa clinical response (HiSCR) score. | 6 months |
| HiSQOL | The Hidradenitis Suppurativa Quality Of Life (HiSQOL) scale, a validated HS quality of life index and is comprised of a 17-item HS-specific HRQOL instrument with a 7-day recall period. Score ranges from 0 to 68, with higher scores indicating more severe impact | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS score | Visual analogue score for pain ranging from 0-10 with higher scores indicating worse pain. | 6 months |
| Pruritus numeric rating scale | As measured by a numeric rating scale from 0-10 with higher scores indicating worse itching. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saritha Research Project Manager | Contact | 570-214-3453 | skorukonda1@geisinger.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mikael K Horissian, MD | Geisinger Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Split-person trial
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| Alexandrite Laser | Device | Alexandrite laser applied to the contralateral side of the participant's body (e.g. left or right) according to randomization, every 4-6 weeks for 4 consecutive treatments. |
|
| 6 months |
| Days free of disease in last 30 days | The number of days a patient has not had a flare of HS in the past 30 days. | 6 months |
| AN Count | Number of abscesses and nodules on exam | 6 months |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |