Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Primary Axillary Hyperhidrosis
• Intervention / Treatment: Device: Fractional microneedle RF(United, Peninsula Medical, China)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospitial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: XJPFMR-201506