Fractionated Microneedle Radiofrequency for Treatment of... | NCT02823340

Studies
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

NCT02823340

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Mar 15, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Primary Axillary Hyperhidrosis

Interventions

Fractional microneedle RF(United, Peninsula Medical, China)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jun 16, 2016

First Submission Date that Met QC Criteria

Jul 5, 2016

First Posted Date

Jul 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2021

Last Update Posted Date

Mar 15, 2021Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fractional Microneedle Radiofrequency Treatment	Experimental	Fractional Microneedle Radiofrequency Treatment	Device: Fractional microneedle RF(United, Peninsula Medical, China)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fractional microneedle RF(United, Peninsula Medical, China)	Device		Fractional Microneedle Radiofrequency Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided