Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

Primary Axillary Hyperhidrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823340
• Other study ID #: XJPFMR-201506
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Device:
• Fractional microneedle RF(United, Peninsula Medical, China)

Locations

Country	Name	City	State
China	Xijing Hospitial	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement of Hyperhidrosis Disease Severity Scale (HDSS)		up to 24 weeks
Secondary	The improvement of visual analog scale(VAS) by patient		0 week, 4weeks, 8weeks, 24 weeks