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OpenTrials
Completed

NCT Number: NCT02823340

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.

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Key information

Conditions

Primary Axillary Hyperhidrosis

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospitial

Xi'an, Shaanxi, 710032, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional microneedle RF(United, Peninsula Medical, China)

Device

Primary outcomes

  1. The improvement of Hyperhidrosis Disease Severity Scale (HDSS)

    Time frame: up to 24 weeks

Secondary outcomes

  1. The improvement of visual analog scale(VAS) by patient

    Time frame: 0 week, 4weeks, 8weeks, 24 weeks

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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