Evaluation of a 1726nm Laser for the Treatment of Hidradenitis Suppurativa (HS)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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• Female or Male.

• Fitzpatrick Skin Types I-VI.

• 18 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Maria V Muniz
mmuniz@med.miami.edu
3056892646
Backup
Leigh Nattkemper, PhD
lxn202@med.miami.edu
3055889734
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 8
Treatments
Experimental: AviClear Group
Participants will be in this group for up to 43 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov