Hidradenitis SuppurativaNCT06801795
Aviclear for Hidradenitis Suppurativa (HS)
A study testing AviClear in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- AviClear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
- No contraindication to laser therapy.
- Willing to undergo biopsy at the beginning of study and end of study.
- Willing to have photographs taken of the treatment area and agree to the use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) or add any new treatment modalities in the treatment area during the study.
- Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.
Who cannot join
- 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.
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- Still healing from another treatment in the target area according to investigator's discretion.
- History of malignant tumors in the target area.
- Excessive hair that may preclude treatments, photos or accurate HS assessments in the target area (okay if shaved).
- Pregnant and/or breastfeeding or planning to become pregnant during the study.
- Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
- History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- 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.
- 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.
- History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- Excessively tanned in the treatment area or unable/unlikely to refrain from tanning in the target area during the study.
- History of keloids or hypertrophic scarring
- Prisoners
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a 1726nm Laser for the Treatment of Hidradenitis Suppurativa (HS)
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
- Being tested
- AviClear
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AviClearDevice
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
| Study group | Role | What they receive |
|---|---|---|
| AviClear Group | Experimental | Participants will be in this group for up to 43 weeks. Receives: Device: AviClear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HiSCR50 as measured by percentage of participants
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50, where HiSCR50 is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
Measured: Baseline, up to 24 weeks (after final treatment)
Secondary outcomes (4)
Change in pain as measured by Visual Analogue Scale Pain Rating Scale
Score range from 0 to 10. Higher score indicates more pain.
Measured: Baseline, up to 24 weeks (after final treatment)
Change in number of lesions
Number of lesions
Measured: Baseline, up to 24 weeks (after final treatment)
Change in IHS 4
The International Hidradenitis Suppurativa 4 (IHS 4) score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Measured: Baseline, up to 24 weeks (after final treatment)
Change in number of Patient's stage category as measured by Hurley Stage
The unit of measure for this outcome is the change in number of patient's stage category. The different Hurley Stages are as follows:
Patient's stage category I: Single of multiple abscess formation without sinus tracts and cicatrization Patient's stage category II: Recurrent single or multiple abscesses, widely separated, with limited sinus tracts and cicatrization Patient's stage category III: Diffuse or near-diffuse involvement of multiple interconnected tracts and abscesses across an entire area
Measured: Baseline, up to 24 weeks (after final treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start12 Feb 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel Eva Eber, University of Miami
- Investigators
- Ariel E Eber, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801795
- Sponsor's protocol ID
- 20240356
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a 1726nm Laser for the Treatment of Hidradenitis Suppurativa (HS)
- ClinicalTrials.gov ID
- NCT06801795
- Acronym / sponsor ID
- 20240356
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AviClear Group | Experimental | Device: AviClearParticipants will be in this group for up to 43 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AviClearParticipants 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 | Device | AviClear Group |
Primary outcome
Change in HiSCR50 as measured by percentage of participants
Time frame: Baseline, up to 24 weeks (after final treatment)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50, where HiSCR50 is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
4 secondary outcomes
Change in pain as measured by Visual Analogue Scale Pain Rating Scale
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in number of lesions
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in IHS 4
Time frame: Baseline, up to 24 weeks (after final treatment)
Change in number of Patient's stage category as measured by Hurley Stage
Time frame: Baseline, up to 24 weeks (after final treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel E Eber, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AviClear in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HiSCR50 as measured by percentage of participants (time frame: Baseline, up to 24 weeks (after final treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.