A Comparative Study for Efficacy and Safety Between Fractional Micro-Needle Radiofrequency (FRM) and Intradermal Botulinum Toxin A for the Treatment of Primary Axillary Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline
研究概览
简要总结
Because of the limiting data about an efficacy and safety of fractional radiofrequency for the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and intradermal Botulinum toxin type A injection for the treatment of primary axillary hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's satisfaction and their quality of life by Dermatology Life Quality Index and side effect between the groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, age between 18-60 years
- •Healthy volunteers
- •Subjects who have experienced with excessive sweating on both sides of axillary areas and have a positive result for iodine starch test on the screening day
- •Willing to participant into the study and voluntary to sign in the informed consent form
排除标准
- •Active bacterial or fungal infection over tested area / axillae
- •Pregnancy and breast feeding
- •Previously underwent the surgical treatment such as radical resection of sweat glands for primary axillary hyperhidrosis
- •Currently being treated with intradermal botulinum toxin type A injection at axillary area for less than 12 months
- •Currently being inserted the cardiac pace maker or any other internal electronic devices
- •Secondary hyperhidrosis caused by hyperthyroidism, drug induced, abnormal autonomic or neurological disorder that affect sweat gland
- •Allergy to botulinum toxin type A
- •Known contact allergy to iodine
- •Unable to follow and comply to the study protocol
研究组 & 干预措施
Fractional Micro-Needle Radiofrequency
each patient will be treated with FMR DeAge®, applicator device at 4-week intervals for 2 sessions of treatment. This applicator consists of rows of 36 (6x6 needles) insulated microneedles that form an array of positively and negatively charged electrodes. The microneedles will deliver bipolar radiofrequency energy in a fractional manner that extends from 3.0 mm below the surface of the skin. All subjects will be prepared by local anesthesia to induce numbness at the axilla prior to treatment. The targeted axillary side will be treated with a total of 4 passes.
干预措施: Fractional Micro-Needle Radiofrequency (Device)
Botulinum toxin type A
50 units of Botulinum toxin type A will be intradermal injected over axillary area. The protocol by using 1-2 units per 1 injection area with the coverage of 1x1 cm2 will be treated.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline
时间窗: 12 weeks
Hyperhidrosis disease severity score will be assessed by study subjects that is categorized to 4 levels; (1) my axillary sweating is never noticeable and never interferes with my daily activities (2) my axillary sweating is tolerable but sometimes interferes with my daily activities (3) my axillary sweating is barely tolerable and frequently interferes with my daily activities (4) my axillary sweating is intolerable and always interferes with my daily activities
次要结局
- Iodine starch test(baseline, week 4 and week 12)
- Adverse effect(12 weeks)
- Participants' satisfaction assessment(week 4 and week 12)
研究者
Thep Chalermchai
Principal Investigator
Mae Fah Luang University Hospital