Primary Axillary Hyperhidrosis
Conditions
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
Interventions
DEVICEFractional microneedle RF(United, Peninsula Medical, China)
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of Hyperhidrosis Disease Severity Scale (HDSS) | up to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of visual analog scale(VAS) by patient | 0 week, 4weeks, 8weeks, 24 weeks |
Countries
China
Outcome results
None listed