Primary Axillary HyperhidrosisNCT02823340
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
A study testing Fractional microneedle RF(United, Peninsula Medical, China) in people with Primary Axillary Hyperhidrosis, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- Fractional microneedle RF(United, Peninsula Medical, China)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- Fractional microneedle RF(United, Peninsula Medical, China)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional microneedle RF(United, Peninsula Medical, China)Device
| Study group | Role | What they receive |
|---|---|---|
| Fractional Microneedle Radiofrequency Treatment | Experimental | Fractional Microneedle Radiofrequency Treatment Receives: Device: Fractional microneedle RF(United, Peninsula Medical, China) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
Measured: up to 24 weeks
Secondary outcomes (1)
The improvement of visual analog scale(VAS) by patient
Measured: 0 week, 4weeks, 8weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Axillary HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xjpfW, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823340
- Sponsor's protocol ID
- XJPFMR-201506
- Status last verified
- Mar 2021
- First submitted
- 16 Jun 2016
- Last updated
- 15 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02823340
- Acronym / sponsor ID
- XJPFMR-201506
- Conditions
- Primary Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional Microneedle Radiofrequency Treatment | Experimental | Device: Fractional microneedle RF(United, Peninsula Medical, China)Fractional Microneedle Radiofrequency Treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional microneedle RF(United, Peninsula Medical, China) | Device | Fractional Microneedle Radiofrequency Treatment |
Primary outcome
The improvement of Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: up to 24 weeks
1 secondary outcome
The improvement of visual analog scale(VAS) by patient
Time frame: 0 week, 4weeks, 8weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional microneedle RF(United, Peninsula Medical, China) in people with Primary Axillary Hyperhidrosis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of Hyperhidrosis Disease Severity Scale (HDSS) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.