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

NCT03054480 | Completed

• 1 other identifier: 109/1-59
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Axillary Hyperhidrosis

Keywords

Fractional Micro-Needle Radiofrequency; Intradermal Botulinum Toxin A

Outcome Measures

Primary Outcomes (1)

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

  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

  12 weeks

Secondary Outcomes (3)

• Iodine starch test

  baseline, week 4 and week 12

• Participants' satisfaction assessment

  week 4 and week 12

• Adverse effect

  12 weeks

Study Arms (2)

Fractional Micro-Needle Radiofrequency

EXPERIMENTAL

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

Botulinum toxin type A

ACTIVE COMPARATOR

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

Interventions

Fractional Micro-Needle Radiofrequency DEVICE

Also known as: DeAgeEX Fractional RF

Fractional Micro-Needle Radiofrequency

Botulinum toxin type A DRUG

Also known as: Neuronox

Botulinum toxin type A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mae Fah Luang University Hospital: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: RCT

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 15, 2017
• Study Start: August 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: January 31, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share