Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis

Not Applicable

Completed

• Conditions: Primary Axillary Hyperhidrosis
• Interventions: Device: Fractional Micro-Needle Radiofrequency; Drug: Botulinum toxin type A

• Registration Number: NCT03054480
• Lead Sponsor: Mae Fah Luang University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-01-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-11
• Study First Posted: 2017-02-15
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional Micro-Needle Radiofrequency	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.
Botulinum toxin type A	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.

Primary Outcome Measures

Name	Time	Method
The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline	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

Secondary Outcome Measures

Name	Time	Method
Iodine starch test	baseline, week 4 and week 12	Qualitative test used to evaluate sudo-motor function (sweating) which method is to apply iodine solution to the skin. Once dry, the area is dusted with cornstarch or potato flour then sweating is encouraged. When sweat reaches the surface of the skin the starch and iodine combine causing a dramatic color change from yellow to dark blue allowing sweat production to be actively visualized.; Photograph from iodine starch test will be assessed by two independent clinical assessors who are blinded to study protocol and grading with score. The investigators will prepare the photo with pre- and post-treatment set. Each set will contain 6 photos, 3 photos from the left and 3 photos from the right. Prepare by using Microsoft PowerPoint program, on each slide will contain 2 photos, pre-treatment photos on the left and post treatment photos on the right. The paired photos will be assessed and graded the score at different time points (4 and 12 weeks) on each side of axilla
Adverse effect	12 weeks	Side effect
Participants' satisfaction assessment	week 4 and week 12	An assessment will be determined at the endpoint visit (4th-12thweek) after the treatment by study subjects by Quartile rating scale on each side of axilla. Quartile rating scale by comparing with the baseline that is categorized to 4 levels; (3) greatly satisfy with treatment result (2) moderately satisfy with treatment result (1) slightly satisfy with treatment result (0) No different with treatment result.