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Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02823340
Recruitment Status : Unknown
Verified February 2016 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : July 6, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Device: Fractional microneedle RF(United, Peninsula Medical, China) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017

Arm Intervention/treatment
Experimental: Fractional Microneedle Radiofrequency Treatment
Fractional Microneedle Radiofrequency Treatment
Device: Fractional microneedle RF(United, Peninsula Medical, China)



Primary Outcome Measures :
  1. The improvement of Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: up to 24 weeks ]

Secondary Outcome Measures :
  1. The improvement of visual analog scale(VAS) by patient [ Time Frame: 0 week, 4weeks, 8weeks, 24 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823340


Locations
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China, Shaanxi
Xijing Hospitial
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02823340     History of Changes
Other Study ID Numbers: XJPFMR-201506
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases