An interventional study of Fractional microneedle RF(United, Peninsula Medical, China) in Primary Axillary Hyperhidrosis, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-03-15.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
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
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Meet the following conditions
Exclusion Criteria:One of the following is not included in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fractional Microneedle Radiofrequency Treatment
Device: Fractional microneedle RF(United, Peninsula Medical, China)
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: up to 24 weeks
The improvement of visual analog scale(VAS) by patient
Time frame: 0 week, 4weeks, 8weeks, 24 weeks
Ran from Mar 2016 to primary completion in Dec 2017, 21 months.
Of 20 interventional studies with no phase under Hyperhidrosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 21 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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