Back to resultsFractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
Primary Purpose
Primary Axillary Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fractional microneedle RF(United, Peninsula Medical, China)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Axillary Hyperhidrosis
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.
Sites / Locations
- Xijing Hospitial
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fractional Microneedle Radiofrequency Treatment
Arm Description
Fractional Microneedle Radiofrequency Treatment
Outcomes
Primary Outcome Measures
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
Secondary Outcome Measures
The improvement of visual analog scale(VAS) by patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02823340
Brief Title
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Axillary Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fractional Microneedle Radiofrequency Treatment
Arm Type
Experimental
Arm Description
Fractional Microneedle Radiofrequency Treatment
Intervention Type
Device
Intervention Name(s)
Fractional microneedle RF(United, Peninsula Medical, China)
Primary Outcome Measure Information:
Title
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
The improvement of visual analog scale(VAS) by patient
Time Frame
0 week, 4weeks, 8weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xijing Hospitial
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
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