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1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)

ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWynn Medical Center

About this trial

Hidradenitis suppurativa (HS) is a long-lasting skin condition that causes painful lumps, abscesses, and tunnels in areas such as the armpits and groin. HS begins around the hair follicle; when the follicle becomes blocked and inflamed, new lesions form. Prior clinical studies of lasers that act on the hair follicle have shown improvement in HS symptoms, and a 1726-nm diode laser-designed to selectively heat oil glands within the follicle-has reduced inflammatory lesions in acne with good tolerability across many skin types.

This study will test whether a 1726-nm diode laser can safely reduce inflammatory HS lesions in Hurley stage I-II disease. Adults with bilateral (right/left) affected areas will be randomized so that one side receives active laser treatment and the other side receives a sham procedure. Participants will have three treatment sessions over 8 weeks and follow-up through Week 24 while continuing their stable HS medications.

The primary outcome is the percent change in abscess and inflammatory nodule counts on the treated side versus the sham side at Week 16. Secondary outcomes include validated HS responder scores, pain, quality of life, flare rate/antibiotic use, and safety. Results may support a non-ablative, follicle-directed option for early HS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults 18-60 years; any sex; Fitzpatrick I-VI.

Clinical HS, Hurley I-II (Investigator confirmed).

At least one inflammatory nodule in a paired, bilateral region (axilla, groin/inguinal, inframammary, inner thigh, or buttock) within 4 weeks prior to baseline.

Able to read/speak English/Chinese/Spanish/Vietnamese and sign consent.

Disqualifiers

Hurley III (extensive sinus tracts).

No qualifying nodule(s) in paired bilateral regions in past 4 weeks.

Prior device/procedure to target areas within 3 months (chemical peel, dermabrasion, microneedling/RF, other lasers/LBB, cryo/chemo-destruction)

Had Botulinum toxin in target areas within 3 months or planned during study.

Trial design

Design model

Crossover

Treatments tested in this trial

  • AviClear Lase Treatment

    Device

    Three laser sessions at Weeks 0, 4, 8; follow-ups at Weeks 12, 16, 24.

  • Sham (No Treatment)

    Device

    No active laser treatment

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Control ArmSham comparator 1 intervention
Group B: Laser TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from HS baseline

Percent change in abscess and inflammatory nodule (AN) count from baseline on the treated side versus the sham side (split-body comparison). HiSCR25 is defined as ≥25% reduction in AN count from baseline, with no increase in abscesses or draining fistulas.

Time frame
16 weeks
2

Change in pain

Change in pain as measured by the Visual Analogue Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain

Time frame
16 weeks

Secondary outcomes

1

Change in depression scale

Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9), a validated nine-item instrument that assesses depression severity over the preceding 16 weeks.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wynn Medical Center

Lead sponsor

Source ClinicalTrials.gov
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