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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03054480
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Thep Chalermchai, 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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Device: Fractional Micro-Needle Radiofrequency Drug: Botulinum toxin type A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Adverse effect [ Time Frame: 12 weeks ]
    Side effect

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: Thep Chalermchai, Principal Investigator, Mae Fah Luang University Hospital Identifier: NCT03054480    
Other Study ID Numbers: 109/1-59
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thep Chalermchai, Mae Fah Luang University Hospital:
Fractional Micro-Needle Radiofrequency
Intradermal Botulinum Toxin A
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents