Active — Not RecruitingNot Applicable

Aviclear for Hidradenitis Suppurativa (HS)

United States8 participantsStarted 2025-02-12

Plain-language 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.

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Change in HiSCR50 as measured by percentage of participants

Timeframe: Baseline, up to 24 weeks (after final treatment)

NCT IDNCT06801795

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.