Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
|ClinicalTrials.gov Identifier: NCT03054480|
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : February 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Axillary Hyperhidrosis||Device: Fractional Micro-Needle Radiofrequency Drug: Botulinum toxin type A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||August 1, 2016|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||January 31, 2017|
Experimental: 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.
Device: Fractional Micro-Needle Radiofrequency
Other Name: DeAgeEX Fractional RF
Active Comparator: 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.
Drug: Botulinum toxin type A
Other Name: Neuronox
- The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline [ Time Frame: 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
- Iodine starch test [ Time Frame: 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
- Participants' satisfaction assessment [ Time Frame: 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.
- Adverse effect [ Time Frame: 12 weeks ]Side effect