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

Primary Axillary Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054480
• Other study ID #: 109/1-59
• Status: Completed
• Phase: N/A
• First received: February 11, 2017
• Last updated: February 15, 2017
• Start date: August 1, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: February 2017
• Source: Mae Fah Luang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Device:
• Fractional Micro-Needle Radiofrequency

Drug:
• Botulinum toxin type A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mae Fah Luang University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Iodine starch test	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	baseline, week 4 and week 12
Secondary	Participants' satisfaction assessment	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.	week 4 and week 12
Secondary	Adverse effect	Side effect	12 weeks