Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

Primary Axillary Hyperhidrosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02823340

XJPFMR-201506

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.