Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa

NCT06960447 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-0947
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Device: Nd:YAG Laser; Device: Alexandrite Laser

Interventions

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.

Receiving treatment with both laser types

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.

Receiving treatment with both laser types

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Geisinger male or female patients with a diagnosis of hidradenitis suppurativa (all stages of disease)
• 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

You may not qualify if:

• Patients who cannot tolerate laser therapy
• Patients who cannot wear protective eyewear
• Patients who are pregnant

Sponsors & Collaborators

• Geisinger Clinic: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Mikael K Horissian, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saritha Research Project Manager

CONTACT

570-214-3453; skorukonda1@geisinger.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: Split-person trial

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share