Comparative Efficacy of Nd:YAG and Alexandrite Laser Treatments in Hidradenitis Suppurativa: A Split-Person, Non-Inferiority Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Geisinger Clinic
- Enrollment
- 21
- Primary Endpoint
- HiSCR50
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Receiving treatment with both laser types
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.
Intervention: Nd:YAG Laser (Device)
Receiving treatment with both laser types
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.
Intervention: Alexandrite Laser (Device)
Outcomes
Primary Outcomes
HiSCR50
Time Frame: 6 months
Percentage of patients achieving a 50% reduction in their hidradenitis suppurativa clinical response (HiSCR) score.
HiSQOL
Time Frame: 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 Outcomes
- Pain VAS score(6 months)
- Pruritus numeric rating scale(6 months)
- Days free of disease in last 30 days(6 months)
- AN Count(6 months)
Investigators
Mickey Horissian
Assistant Professor of Dermatology
Geisinger Clinic