MedTrace Logo

Intralesional Diode Laser Treatment of Fistulas in Hidradenitis Suppurativa

NCT04508374 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-02

No results posted yet for this study

Summary

Hidradenitis suppurativa (HS) is a common chronic skin disease where patients experience inflamed painful nodules and chronic suppurating tunnels under the skin that often leave mutilating scars. Symptoms typically begin during adolescence and patients struggle with pain, pruritus, malodor and purulent discharge compromising work life, physical exercise, and sexual habits. Consequently, the risk of social exclusion, anxiety, depression, and suicide is increased among patients suffering from HS.

Creams, tablets, and injections aim to gain disease control, yet are sometimes not sufficient. Once HS tunnels have formed, surgical intervention is often required.

Recently, emergence of flexible diode laser fibers has enabled treatment of tunnels from within. The technique has been tested for perianal tunnels and in few studies also for HS tunnels with promising results. Overall, the laser fiber technique is still new, and knowledge of optimal treatment settings is sparse. However, there is reason to believe that intralesional laser fiber treatment of HS tunnels may provide a new tissue-sparing alternative to conventional surgical techniques with a potential to produce fewer side effects, less scaring, shorter downtime after surgery and possibly, also improved inflammatory control.

This study aims to investigate the efficacy and safety of laser fiber treatment of HS tunnels.

Method The project is carried out at the Dermatological Department, Roskilde University Hospital under the leadership of principal investigator Professor DmSc Gregor Jemec.

A prospective cohort study of intralesional laser fiber treatment of HS fistulas is planned.

After signing informed consent, patients with two comparable HS tunnels in typical areas will draw lot to receive experimental laser fiber treatment of one tunnel while the other tunnel serve as control. Efficacy will be monitored by pain scores, ultrasound, clinical photos, clinical measures of disease activity, quality-of-life scores, and skin biopsies. Patients will be followed 2, 6, 12 weeks and if possible, also 52 weeks after treatment. After 12 weeks, patients will be offered laser fiber treatment or standard of care surgery to the untreated control tunnel.

Conditions

Interventions

PROCEDURE

1470 nm intra-lesional diode laser treatment of right HS tunnel

Ten patients: 1470 nm intra-lesional diode laser treatment of right HS-tunnel randomized to active treatment.

PROCEDURE

1470 nm intra-lesional diode laser treatment of left HS tunnel

Ten patients: 1470 nm intra-lesional diode laser treatment of left HS-tunnel randomized to active treatment.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Gregor BE Jemec, DmSc, Prof. · Zealand University Hospital - Roskilde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2022-09-30
Completion
2025-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508374 on ClinicalTrials.gov