Back to resultsFractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
Primary Purpose
Primary Axillary Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractional Micro-Needle Radiofrequency
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Primary Axillary Hyperhidrosis focused on measuring Fractional Micro-Needle Radiofrequency, Intradermal Botulinum Toxin A
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fractional Micro-Needle Radiofrequency
Botulinum toxin type A
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Adverse effect
Side effect
Full Information
NCT ID
NCT03054480
First Posted
February 11, 2017
Last Updated
February 15, 2017
Sponsor
Mae Fah Luang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03054480
Brief Title
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mae Fah Luang University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Axillary Hyperhidrosis
Keywords
Fractional Micro-Needle Radiofrequency, Intradermal Botulinum Toxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fractional Micro-Needle Radiofrequency
Arm Type
Experimental
Arm 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.
Arm Title
Botulinum toxin type A
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Fractional Micro-Needle Radiofrequency
Other Intervention Name(s)
DeAgeEX Fractional RF
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Neuronox
Primary Outcome Measure Information:
Title
The change of Hyperhidrosis disease severity score (HDSS) at week-12 with the baseline
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Iodine starch test
Description
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
Time Frame
baseline, week 4 and week 12
Title
Participants' satisfaction assessment
Description
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.
Time Frame
week 4 and week 12
Title
Adverse effect
Description
Side effect
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
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