Hidradenitis Suppurativa (HS)
Conditions
Brief summary
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).
Interventions
DEVICENd:YAG Laser
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.
DEVICEAlexandrite Laser
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.
Sponsors
Geisinger Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Split-person trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Geisinger male or female patients with a diagnosis of hidradenitis suppurativa (all stages of disease) * 12-75 years of age * Not on concurrent systemic therapy (e.g., antibiotics, biologic therapies) * Must have not used systemic therapies within 2 weeks of enrollment in study * Able and willing to provide consent
Exclusion criteria
* Patients who cannot tolerate laser therapy * Patients who cannot wear protective eyewear * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HiSCR50 | 6 months | Percentage of patients achieving a 50% reduction in their hidradenitis suppurativa clinical response (HiSCR) score. |
| HiSQOL | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS score | 6 months | Visual analogue score for pain ranging from 0-10 with higher scores indicating worse pain. |
| Pruritus numeric rating scale | 6 months | As measured by a numeric rating scale from 0-10 with higher scores indicating worse itching. |
| Days free of disease in last 30 days | 6 months | The number of days a patient has not had a flare of HS in the past 30 days. |
| AN Count | 6 months | Number of abscesses and nodules on exam |
Contacts
Primary ContactSaritha Research Project Manager
Outcome results
None listed