Aviclear for Hidradenitis Suppurativa (HS)

NCT ID: NCT06801795

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2026-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AviClear Group

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

Group Type: EXPERIMENTAL

AviClear

Intervention Type: 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

Interventions

AviClear

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ariel Eva Eber

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel E Eber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maria V Muniz

Role: CONTACT

mmuniz@med.miami.edu

3056892646

Leigh Nattkemper, PhD

Role: CONTACT

lxn202@med.miami.edu

3055889734

Facility Contacts

Maria Muniz

Role: primary

mmuniz@med.miami.edu

3056892646

Other Identifiers

20240356

Identifier Type: -

Identifier Source: org_study_id