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Completed

NCT Number: NCT03054480

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

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.

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Key information

Conditions

Primary Axillary Hyperhidrosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional Micro-Needle Radiofrequency

Device

Other names: DeAgeEX Fractional RF

Botulinum Toxin Type A

Drug

Other names: Neuronox

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mae Fah Luang University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 15, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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