Aviclear for Hidradenitis Suppurativa (HS) (NCT06801795) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HiSCR50 as measured by percentage of participants
Timeframe: Baseline, up to 24 weeks (after final treatment)
. 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.