Clinical trial NCT06801795: Aviclear for Hidradenitis Suppurativa (HS)
Official title: Evaluation of a 1726nm Laser for the Treatment of Hidradenitis Suppurativa (HS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Female or Male.
2. Fitzpatrick Skin Types I-VI.
3. 18 to 60 years of age.
4. Has a clinical diagnosis of HS (stage 1-2 on the Hurley scale \[Appendix 1\] based on assessment by the investigator).
5. Presence of nodule(s) in the bilateral axillas, inguinal, infra-mammary, thighs, or buttocks within the past 4 weeks
6. Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
7. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
8. No contraindication to laser therapy.
9. Willing to undergo biopsy at the beginning of study and end of study.
10. Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
11. Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
12. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

Exclusion Criteria:

1. Has clinically diagnosed HS of severity grade 3 based on assessment by the investigator.
2. Absence of nodule(s) in the bilateral axilla, inguinal, infra-mammary, thighs, or buttocks within the past 4 weeks.
3. 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.
4. 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.
5. Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study.
6. Systemic use of retinoid, such as isotretinoin, within 3 months of study participation.
7. Still healing from another treatment in the target area according to investigator's discretion.
8. History of malignant tumors in the target area.
9. Excessive hair that may preclude treatments, photos or accurate HS assessments in the target area (okay if shaved).
10. Pregnant and/or breastfeeding or planning to become pregnant during the study.
11. Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
12. History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
13. History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
14. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
15. 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.
16. History of radiation to the target area, currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
17. History of diagnosed pigmentary disorders (including vitiligo) in the target area.
18. Excessively tanned in the treatment area or unable/unlikely to refrain from tanning in the target area during the study.
19. History of keloids or hypertrophic scarring
20. Prisoners
21. As per the Investigator's discretion, any physical, mental or medical condition which might make it unsafe for the subject to participate in this study, might interfere with patient's participation in the full study protocol, or might interfere with the diagnosis or assessment of HS.

Primary outcomes:
measure: Change in HiSCR50 as measured by percentage of participants
timeFrame: Baseline, up to 24 weeks (after final treatment)
Secondary outcomes:
measure: Change in pain as measured by Visual Analogue Scale Pain Rating Scale
timeFrame: Baseline, up to 24 weeks (after final treatment)
measure: Change in number of lesions
timeFrame: Baseline, up to 24 weeks (after final treatment)
measure: Change in IHS 4
timeFrame: Baseline, up to 24 weeks (after final treatment)
measure: Change in number of Patient's stage category as measured by Hurley Stage
timeFrame: Baseline, up to 24 weeks (after final treatment)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ariel E Eber, MD
role: PRINCIPAL_INVESTIGATOR
References: