Aviclear for Hidradenitis Suppurativa (HS)

NCT06801795 | Active Not Recruiting FDA Device

• 1 other identifier: 20240356
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the safety and efficacy of the Cutera 1726 nm laser system (also referred to as AviClear) for the treatment of HS.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Change in HiSCR50 as measured by percentage of participants

  Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50, where HiSCR50 is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.

  Baseline, up to 24 weeks (after final treatment)

Secondary Outcomes (4)

• Change in pain as measured by Visual Analogue Scale Pain Rating Scale

  Baseline, up to 24 weeks (after final treatment)

• Change in number of lesions

  Baseline, up to 24 weeks (after final treatment)

• Change in IHS 4

  Baseline, up to 24 weeks (after final treatment)

• Change in number of Patient's stage category as measured by Hurley Stage

  Baseline, up to 24 weeks (after final treatment)

Study Arms (1)

AviClear Group

EXPERIMENTAL

Participants will be in this group for up to 43 weeks.

Device: AviClear

Interventions

AviClear DEVICE

Participants will receive as many as 4 treatments, each treatment lasts approximately 10 minutes, with intervals of up to 5 weeks apart. The treatments will be conducted in person. Participants will be followed at approximately week 5 post-treatment completion (via phone) at 12 weeks and 24 weeks post treatment completion onsite. This is a 1726 nanometer laser treatment

AviClear Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or Male.
• Fitzpatrick Skin Types I-VI.
• to 60 years of age.
• Has a clinical diagnosis of HS (stage 1-2 on the Hurley scale \[Appendix 1\] based on assessment by the investigator).
• Presence of nodule(s) in the bilateral axillas, inguinal, infra-mammary, thighs, or buttocks within the past 4 weeks
• Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
• Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
• No contraindication to laser therapy.
• Willing to undergo biopsy at the beginning of study and end of study.
• Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
• Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
• Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

You may not qualify if:

• Has clinically diagnosed HS of severity grade 3 based on assessment by the investigator.
• Absence of nodule(s) in the bilateral axilla, inguinal, infra-mammary, thighs, or buttocks within the past 4 weeks.
• Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
• Prior treatment to the target area within 3 months of study participation including chemical peel, dermabrasion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
• Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
• Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
• Still healing from another treatment in the target area according to investigator's discretion.
• History of malignant tumors in the target area.
• Excessive hair that may preclude treatments, photos or accurate HS assessments in the target area (okay if shaved).
• Pregnant and/or breastfeeding or planning to become pregnant during the study.
• Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
• History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

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

Study Officials

• Ariel E Eber, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

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 Clinical

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)