Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

NCT ID: NCT02823340

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2017-12-31

Brief 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.

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

Conditions

Primary Axillary Hyperhidrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional Microneedle Radiofrequency Treatment

Fractional Microneedle Radiofrequency Treatment

Group Type: EXPERIMENTAL

Fractional microneedle RF(United, Peninsula Medical, China)

Intervention Type: DEVICE

Interventions

Fractional microneedle RF(United, Peninsula Medical, China)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

chief of dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xijing Hospitial

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XJPFMR-201506

Identifier Type: -

Identifier Source: org_study_id