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

Mae Fah Luang University Hospital

Status: Completed

Conditions: Primary Axillary Hyperhidrosis

Treatments: Device: Fractional Micro-Needle Radiofrequency; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03054480

109/1-59

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Fractional Micro-Needle Radiofrequency

Experimental group

Description:

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.

Treatment:

Device: Fractional Micro-Needle Radiofrequency

Botulinum toxin type A

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin type A