Intralesional Diode Laser Treatment of Fistulas in Hidradenitis Suppurativa: Protocol for a Within-person Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- VAS pain
研究概览
简要总结
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.
详细描述
Background and aim:
Hidradenitis suppurativa (HS) is a common chronic skin disease that manifests by intermittent flare-ups of inflamed painful nodules that often leave mutilating scars, chronic suppurating tunnels and a changed microbiome compared to normal skin. 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.
Topical and systemic medical treatments, e.g. in the form of antibiotics, vitamin A derivates, immune-modulatory drugs or biological therapies aim to control inflammation. Once fistulas have formed, surgical intervention is often required. Present surgical therapies comprise surgical deroofing where the fistulas are cut open and left to heal, removal of specific pathological structures by ablative laser surgery or complete surgical removal en bloc of affected HS skin followed by skin grafting.
Recently, emergence of flexible diode laser fibers has enabled intra-lesional laser treatments of fistulas and the technique has been applied for e.g. perianal fistulas. Two prospective and one retrospective cohort studies evaluated a total of 265 patients treated with 1470 nm laser fiber surgery for perianal fistulas, demonstrating primary healing with absence of symptoms after one treatment in 40% to 71% of patients, a median healing time of 5 weeks, and long-term closure beyond 12 months in 71% of patients6. Intralesional laser fiber treatment has also been tested in HS tunnels. One study of concomitant 630 nm laser fiber treatment and photodynamic therapy has demonstrated a significant reduction in hidradenitis severity score and complete response in 47 % of patients after one treatment session.
Intralesional flexible laser fibers have also been tested in the treatment of HS tunnels without concomitant photodynamic therapy. One study investigated four sessions of 1064 nm intralesional diode laser therapy performed in local anesthesia. In a total of 20 patients, a significant reduction of Sartorius score and improved quality of life was demonstrated. No patients experienced neither worsening of disease nor complete cure and adverse effects were mild and transient. It was proposed, that intralesional laser treatment may elicit a decontaminating as well as an denaturing effect. Histological evaluation of endo-venous 1470 nm laser fiber treatment have demonstrated uniform coagulation without carbonization. Overall, the intralesional laser fiber technique is still new, and knowledge of optimal laser wave lengths, energy levels, number of treatments and treatment intervals is sparse. In addition, little is known about laser-tissue interactions in vivo as well as in vitro. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluation of clinical photos and percentage closure by Ultrasound will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legally competent women and men
- •aged 18 years or older
- •Two appropriate HS fistulas
排除标准
- •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
结局指标
主要结局
VAS pain
时间窗: At baseline, 2, 6, and 12 weeks from baseline
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
次要结局
- Change in Physician's global assessment (PGA)(At baseline, 2, 6 and 12 weeks post treatment)
- Number of treated and control tunnels acquiring rescue therapy(At baseline, 2, 6 and 12 weeks post treatment)
- Suppuration(At baseline, 2, 6 and 12 weeks post treatment)
- Lesion count(At baseline, 2, 6 and 12 weeks post treatment)
- Described number of flares(At baseline, 2, 6 and 12 weeks post treatment)
- 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)
- Change in Patients global assessment (PtGA)(At baseline, 2, 6 and 12 weeks post treatment)
研究者
Gregor Jemec
Professor, PhD, DmsC, Head of Dpt.
Zealand University Hospital