RECRUITING

Aviclear for Hidradenitis Suppurativa (HS)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-12

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06801795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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) with bilateral involvement in the axilla or inguinal area, and at least two nodules present on either the left or right side on the day of evaluation. 5. Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form. 6. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions. 7. No contraindication to laser therapy. 8. Willing to undergo biopsy at the beginning of study and end of study. 9. Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes. 10. Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study. 11. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.	1. Has clinically diagnosed HS of severity grade 3 on the left and/or right axilla and/or inguinal area based on investigator review using the Hurley scale. 2. Unilateral involvement in the axilla or inguinal area, and less than two nodules present on either the left or right side on the day of evaluation. 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.

Inclusion Criteria

Exclusion 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) with bilateral involvement in the axilla or inguinal area, and at least two nodules present on either the left or right side on the day of evaluation.
5. Subject must be able to read, speak, and understand English or Spanish and sign the Informed Consent Form.
6. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
7. No contraindication to laser therapy.
8. Willing to undergo biopsy at the beginning of study and end of study.
9. Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
10. Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
11. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.

1. Has clinically diagnosed HS of severity grade 3 on the left and/or right axilla and/or inguinal area based on investigator review using the Hurley scale.
2. Unilateral involvement in the axilla or inguinal area, and less than two nodules present on either the left or right side on the day of evaluation.
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.

Contacts and Locations

Study Contact

Maria V Muniz

CONTACT

3056892646

mmuniz@med.miami.edu

Leigh Nattkemper, PhD

CONTACT

3055889734

lxn202@med.miami.edu

Principal Investigator

Ariel E Eber, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Ariel E Eber, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2025-02-12

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa