Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

Study Overview
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Brief Summary
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Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and 24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit.

Detailed Description
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Hyperhidrosis Disease Severity Scale (HDSS)Score = 1 My sweating is never noticeable and never interferes with my daily activitiesScore = 2 My sweating is tolerable but sometimes interferes with my daily activitiesScore = 3 My sweating is barely tolerable and frequently interferes with my daily activitiesScore = 4 My sweating is intolerable and always interferes with my daily activities

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Device: Fractional microneedle RF(United, Peninsula Medical, China)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the following conditions Diagnosed according to having a score of 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS); Patients aged 18 to 40 years (to the date of screening); Not treatment in Axillary area before; Understanding the whole process of the study, voluntary participation and signed the informed consent; Patient compliance is good, can guarantee in course of observation. Exclusion Criteria:One of the following is not included in this study: Pregnant women, ready to pregnant or lactating women; Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history Need insulin control of diabetes; High blood pressure did not get good controller ; Patients with white blood cells <4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets <100 × 109 / L, or other blood disease; Patients with chronic diarrhea, or peptic ulcer nearly 1 year; Patients suffering from malignant tumor; Patients suffering from acute and chronic infectious diseases; Mental disorders, history of alcohol abuse, drug or other substance abuse; Other cases which researchers believe that can not enroll.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional Microneedle Radiofrequency Treatment<br>Fractional Microneedle Radiofrequency Treatment | Device: Fractional microneedle RF(United, Peninsula Medical, China)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of Hyperhidrosis Disease Severity Scale (HDSS) |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of visual analog scale(VAS) by patient |  | 0 week, 4weeks, 8weeks, 24 weeks |