Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

NCT02823340 | Completed

• 1 other identifier: XJPFMR-201506
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• The improvement of Hyperhidrosis Disease Severity Scale (HDSS)

  up to 24 weeks

Secondary Outcomes (1)

• The improvement of visual analog scale(VAS) by patient

  0 week, 4weeks, 8weeks, 24 weeks

Study Arms (1)

Fractional Microneedle Radiofrequency Treatment

EXPERIMENTAL

Fractional Microneedle Radiofrequency Treatment

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

Interventions

Fractional microneedle RF(United, Peninsula Medical, China) DEVICE

Fractional Microneedle Radiofrequency Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospitial

Xi'an, Shaanxi, 710032, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of dermatology

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 6, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

CN (1)