Intralesional Diode Laser Treatment of Fistulas in Hidradenitis Suppurativa

NCT04508374 | Unknown

• 1 other identifier: 19- 001165
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• VAS pain

  change in pain score on a visual analogue scale (where 0 is no pain =better; 10 is maximum pain = worse) for each individual HS-tunnel

  At baseline, 2, 6, and 12 weeks from baseline

Secondary Outcomes (8)

• ultrasound

  At baseline, and 12 weeks from baseline

• Blinded evaluation of improvement of left/right tunnel (yes/no) in clinical photographs

  At baseline, 2, 6 and 12 weeks post treatment

• Lesion count

  At baseline, 2, 6 and 12 weeks post treatment

• Change in Patients global assessment (PtGA)

  At baseline, 2, 6 and 12 weeks post treatment

• Change in Physician's global assessment (PGA)

  At baseline, 2, 6 and 12 weeks post treatment

Other Outcomes (6)

• Changes in Microbiome by investigation of skin biopsies

  At baseline and 6 weeks from baseline

• Thermography

  At baseline, 2, 6, and 12 weeks from baseline

• Dermatology Life Quality index (DLQI) questionnaire

  baseline

Study Arms (2)

1470 nm diode laser treatment of right HS-fistula

EXPERIMENTAL

This is an intra-person study, comparing outcomes within participants. All participants will receive active 1470 nm intra-lesional diode laser treatment on one HS tunnel. Half of the enroled patients will receive active treatment of the right side, while the HS tunnel on the left side will be left as an untreated control.

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

1470 nm diode laser treatment of left HS-fistula

EXPERIMENTAL

This is an intra-person study, comparing outcomes within participants. All participants will receive active 1470 nm intra-lesional diode laser treatment on one HS tunnel. Half of the enroled patients will receive active treatment of the left side, while the HS tunnel on the right side will be left as an untreated control.

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

Interventions

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

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

1470 nm diode laser treatment of right HS-fistula

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

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

1470 nm diode laser treatment of left HS-fistula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legally competent women and men
• aged 18 years or older
• Two appropriate HS fistulas

You may not qualify if:

• fistulas in areas that have previously received surgery
• Allergy to lidocaine or adrenaline
• Fragile physical health that cannot tolerate standard of care HS rescue therapy
• Pregnant or lactating women

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

zealand University Hospital Roskilde

Roskilde, 4000, Denmark

RECRUITING

Related Publications (8)

• Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032. doi: 10.1001/jama.2017.16691.

  PMID: 29183082 BACKGROUND

• Ring HC, Thorsen J, Saunte DM, Lilje B, Bay L, Riis PT, Larsen N, Andersen LO, Nielsen HV, Miller IM, Bjarnsholt T, Fuursted K, Jemec GB. The Follicular Skin Microbiome in Patients With Hidradenitis Suppurativa and Healthy Controls. JAMA Dermatol. 2017 Sep 1;153(9):897-905. doi: 10.1001/jamadermatol.2017.0904.

  PMID: 28538949 BACKGROUND

• Thorlacius L, Cohen AD, Gislason GH, Jemec GBE, Egeberg A. Increased Suicide Risk in Patients with Hidradenitis Suppurativa. J Invest Dermatol. 2018 Jan;138(1):52-57. doi: 10.1016/j.jid.2017.09.008. Epub 2017 Sep 20.

  PMID: 28942360 BACKGROUND

• Terzi MC, Agalar C, Habip S, Canda AE, Arslan NC, Obuz F. Closing Perianal Fistulas Using a Laser: Long-Term Results in 103 Patients. Dis Colon Rectum. 2018 May;61(5):599-603. doi: 10.1097/DCR.0000000000001038.

  PMID: 29528908 BACKGROUND

• Wilhelm A, Fiebig A, Krawczak M. Five years of experience with the FiLaC laser for fistula-in-ano management: long-term follow-up from a single institution. Tech Coloproctol. 2017 Apr;21(4):269-276. doi: 10.1007/s10151-017-1599-7. Epub 2017 Mar 7.

  PMID: 28271331 BACKGROUND

• Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.

  PMID: 25724967 BACKGROUND

• Suarez Valladares MJ, Eiris Salvado N, Rodriguez Prieto MA. Treatment of hidradenitis suppurativa with intralesional photodynamic therapy with 5-aminolevulinic acid and 630nm laser beam. J Dermatol Sci. 2017 Mar;85(3):241-246. doi: 10.1016/j.jdermsci.2016.12.014. Epub 2016 Dec 19.

  PMID: 28034606 BACKGROUND

• Fabbrocini G, Franca K, Lotti T, Marasca C, Annunziata MC, Cacciapuoti S, Masara A, Romanelli M, Lotti J, Wollina U, Tchernev G, Zerbinati N. Intralesional Diode Laser 1064 nm for the Treatment of Hidradenitis Suppurativa: A Report of Twenty Patients. Open Access Maced J Med Sci. 2018 Jan 7;6(1):31-34. doi: 10.3889/oamjms.2018.045. eCollection 2018 Jan 25.

  PMID: 29483975 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Gregor BE Jemec, DmSc, Prof.

  Zealand University Hospital - Roskilde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregor BE Jemec, Prof., DmSc

CONTACT

+4547322600; gbj@regionsjaelland.dk

Elisabeth H Taudorf, MD, PhD

CONTACT

+4547322600; etau@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluation of clinical photos and percentage closure by Ultrasound will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, DmsC, Head of Dpt.

Model Details: The study is designed as a randomised, contralaterally-controlled, within-person design, where HS patients are randomised to undergo intralesional laser fibre treatment of HS tunnels in either right or left side of the body, whereas the other tunnel is left as an untreated control.

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 11, 2020
• Study Start: December 10, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2025
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)