Treatment of Axillary Hyperhidrosis With Long-pulsed Nd:YAG Laser or IPL Using Dynamic Optical Coherence Tomography Imaging of Laser-Tissue Interaction: Protocol for a Within-person Randomised Trial Conditioning on Treatment Type
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in sweat production measured by Iodine-starch test
研究概览
简要总结
SUMMARY Objective To assess the efficacy of Nd:YAG laser treatment on eccrine sweat production in the axillae of persons experiencing excessive axillary hyperhidrosis.
Design Randomised, within-person controlled clinical trial.
Setting One Dermatology Department, at a University hospital in Denmark, from 2018-20.
Participants A total of 10 participants enrolled after signing informed consent from the patients attending the hyperhidrosis clinic.
Interventions Participants will receive one Nd:YAG laser-treatment of either left or right axilla. The treated area will be cooled with ice during and after laser treatment. Prior to treatment, patients can use lidocaine-prilocaine 5% cream at the treatment site on an optional basis.
Main outcome measures Primary outcome measure will be reduced excessive sweat production (%points) monitored by an iodine-starch test assessed at 1-month follow-up compared to baseline. A 30% reduction in sweat production in the Nd:YAG laser-treatment relative to control, will be considered clinically significant.
Key secondary outcome measures include (1) weighing the sweat by gravimetric testing, (2) patient assessment of sweat production on a Hyperhidrosis Disease Severity Scale (HDSS) - also assessed at 1 month from baseline. Safety around the use of Nd:YAG laser-treatment will be monitored by registering pain during treatment on a visual analogue scale, as well as monitoring of adverse events immediately as well as one week after treatment. As for the purpose of further exploratory analyses (both benefits and harms), all outcome measures will be re-collected 24 months after treatment.
Timelines and dissemination For the collection of the primary data (i.e. primary endpoint being assessed after 1 month), First Patient First Visit (FPFV) will take place in November 2018 and Last Patient Last Visit (LPLV) will be in March 2019.
The investigators plan to present data internationally at e.g. the European Academy of Dermatology and Venerology as well as nationally to the Danish Dermatology Society and to the Hyperhidrosis Patient Association. Results will be published in an internationally recognised peer reviewed (biomedical) journal.
Trial registration: Danish Research Ethics Committee (approved, protocol number: SJ-689); ClinicalTrials.gov: NCT pending (2018-11-22).
详细描述
INTRODUCTION Primary axillary hyperhidrosis is a condition with excessive secretion of sweat from the eccrine sweat glands of the armpits that affects between 1 and 5 % of the world's population. Numbers may be underestimated since this chronical disease debuts during adolescence and is unmentionable in many cultures and social environments. Hyperhidrosis may lead to malodour and cause large sweat patches on clothes, thus affecting dressing behaviour, social activities and job opportunities. As a direct consequence, many patients experience affected psychological and social behaviour, increased mental stress and low self-esteem.
Several treatment modalities exist that may treat axillary hyperhidrosis. Systemic treatment with anticholinergic tablets is often reserved to hyperhidrosis that affects the entire body due to a substantial risk of adverse effects. Possible adverse effects (i.e. related to the intervention) include dry mouth and other mucous membranes, digestive problems, decreased ability to empty the bladder, visual disturbances and affected nervous system. Localised axillary hyperhidrosis is often treated by injections of botulinum toxin. Although this method is effective in many patients the procedure is painful, expensive and has to be repeated since the effect only last from four to nine months. Recently, heating of the sweat glands with microwave technology has shown promising efficacy with minimal adverse effects. However, this treatment is very expensive and is only available at a few sites in Denmark. Surgery has also been performed, yet short-term and long-term efficiency is inferior to other methods. Therefore, there is a need for efficient, safe, affordable and widely available alternatives to treat axillary hyperhidrosis.
An alternative method that have been proposed, could be heating and destroying sweat glands by Neodynium Yttrium Aluminium Garnet (Nd:YAG) laser or intensed pulsed light (IPL). These types of non-invasive light devices are widely available at dermatological clinics in Europe and is well-known to treat vascular lesions and undesired hair growth. The IPL has a 640 - 800 nm wavelength and the Nd:YAG laser a 1064 nm wavelength that penetrates deeply into the skin and target the melanin of the hair shaft. By adjusting the pulse length according to the theory of extended photo-thermolysis, light energy can be delivered through the hair shaft into surrounding sweat glands. A previous pilot study has demonstrated significant and lasting reduction of axillary hyperhidrosis in six patients treated with Nd:YAG laser.Treatments were reported safe and efficient without any side effects. Likewise, two studies of a comparable but invasive Nd:YAG laser technique reported only temporary mild adverse effects and significant sweat reduction for up to 43 months after treatment. A single prospective study without a control group demonstrated increased sweat production following Nd:YAG laser treatment of excessive hair growth. Targeting hair and sweat glands is however not directly comparable due to different pulse lengths of the delivered energy.
Dynamic optic coherence tomography (d-OCT) is an imaging technique that utilizes infrared light to create two-dimensional horizontal or transverse images. Penetration depth is approximately 0.5 - 2 mm 11. The d-OCT technique allows in situ visualization of dynamic changes in blood flow and superficial skin structures in vital skin. Thus, the eccrine sweat glands and the surrounding blood supply can be followed over time without taking invasive tissue biopsies. Previous studies of histological changes after laser treatment of eccrine sweat glands have only been able to demonstrate limited structural changes and therefore, there is a need for improved imaging techniques to visualize laser-tissue-interactions.
Aim & Objectives To assess the efficacy and safety of experimental intervention (either Nd:YAG laser OR IPL treatment) of an axilla with hyperhidrosis, relative to the contralateral untreated side, and to visualise laser-tissue interactions by Dynamic Optical Coherence Tomography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years
- •Fitzpatrick skin type I-III
- •Suffering from severe axillary hyperhidrosis characterised by a value of 3 or 4 on the HDDS scale.
排除标准
- •Use of photosensitizing medication
- •Active treatments for axillary hyperhidrosis within the last five months.
- •Wounds, scars or skin disease in the Axillae
- •Prior surgery, laser or microwave therapy in the axilla
- •Pregnancy or lactation
结局指标
主要结局
Change in sweat production measured by Iodine-starch test
时间窗: from baseline to one-month post-treatment
Reduction of sweat area measured by the percentage reduction of dark-colored area in the axilla one month after treatment measured by the iodine-starch test
次要结局
- OCT scan of laser-tissue interactions(from baseline to one-month post-treatment)
- Change in hyperhidrosis disease severity scale (HDSS)(from baseline to one-month post-treatment)
- Change in sweat production measured by Gravimetric testing(from baseline to one-month post-treatment)
研究者
Gregor Jemec
Professor, PhD, DmsC, Head of Dpt.
Zealand University Hospital