Axillary HyperhidrosisNCT07094009
Comparison of the Clinical Efficacy and Adverse Reactions of Different Needling Patterns of High-frequency Microneedles in the Treatment of Axillary Odor
A study testing received transverse needling, received vertical needling and received mixed needling in people with Axillary Hyperhidrosis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Background: Axillary osmidrosis is a common skin disease characterized by an unpleasant odor produced when secretions from apocrine sweat glands in the armpits are decomposed by bacteria on the skin. It affects people's social interactions and psychology. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- received transverse needling, received vertical needling and received mixed needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 1 Apr 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion criteria: 1) aged from 18 to 50; 2) the axillary odor classified as Grade 2 or 3; 3) without previous history of axillary odor treatment; 4) willingly participated and provided their informed consent.
Exclusion criteria: Patients who met any of the following conditions must be excluded from this study: 1) with other skin diseases in the axilla that may worsen the condition or according to the investigator, may affect the evaluation of the trial results; 2) patients with cicatricial diathesis or needle phobia; 3) patients who were pregnant or lactating; 4) patients with coagulation disorder or immunodeficiency diseases
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Chongqing Medical Uiversity
Chongqing, Chongqing Municipality, 400016
About this study
- Background: Axillary osmidrosis is a common skin disease characterized by an unpleasant odor produced when secretions from apocrine sweat glands in the armpits are decomposed by bacteria on the skin. It affects people's social interactions and psychology. Gold microneedle is a method for treating axillary osmidrosis, which achieves the therapeutic purpose by destroying the glands through radiofrequency heating. However, it remains unknown whether different movement patterns have an impact on the therapeutic effect and adverse reactions.
- Purpose and expected outcomes: This study intends to prospectively collect patients with axillary osmidrosis who visit our hospital, randomly divide them into the horizontal row movement, vertical row movement and mixed movement pattern groups, evaluate the efficacy and occurrence of adverse reactions, and further understand the impact of different microneedle movement patterns on the treatment of axillary osmidrosis.
- Design and methods: Patients who visit our hospital and are willing to receive gold microneedle treatment will be randomly divided into the horizontal row movement, vertical row movement and mixed movement pattern groups. A disposable sterile gold microneedle treatment head will be installed, and different parameters will be set according to the elasticity of the patient's underarm skin and the thickness of subcutaneous fat. The entire radiofrequency treatment area will be covered using horizontal row movement, vertical row movement and mixed movement patterns respectively. All three groups will be closely followed up after the operation; during each follow-up, patients will be required to perform the same exercise load as before the operation to evaluate the therapeutic effect and recurrence.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- received transverse needling, received vertical needling, received mixed needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
received transverse needlingProcedure or surgery
received transverse needling of high-frequency microneedles
received vertical needlingProcedure or surgery
received vertical needling of high-frequency microneedles
received mixed needlingProcedure or surgery
received mixed needling of high-frequency microneedles
| Study group | Role | What they receive |
|---|---|---|
| transverse needling group | Experimental | received transverse needling Receives: Procedure: received transverse needling |
| vertical needling group | Experimental | received vertical needling Receives: Procedure: received vertical needling |
| mixed needling group | Experimental | received mixed needling Receives: Procedure: received mixed needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
Measured: 6 months
Secondary outcomes (2)
effective rate
Measured: 6 months
recurrece rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Oct 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengcheng Shen, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094009
- Sponsor's protocol ID
- 2023-435
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy and Adverse Reactions of Different Needling Patterns of High-frequency Microneedles in the Treatment of Axillary Odor
- ClinicalTrials.gov ID
- NCT07094009
- Acronym / sponsor ID
- 2023-435
- Conditions
- Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- 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.
- Background: Axillary osmidrosis is a common skin disease characterized by an unpleasant odor produced when secretions from apocrine sweat glands in the armpits are decomposed by bacteria on the skin. It affects people's social interactions and psychology. Gold microneedle is a method for treating axillary osmidrosis, which achieves the therapeutic purpose by destroying the glands through radiofrequency heating. However, it remains unknown whether different movement patterns have an impact on the therapeutic effect and adverse reactions.
- Purpose and expected outcomes: This study intends to prospectively collect patients with axillary osmidrosis who visit our hospital, randomly divide them into the horizontal row movement, vertical row movement and mixed movement pattern groups, evaluate the efficacy and occurrence of adverse reactions, and further understand the impact of different microneedle movement patterns on the treatment of axillary osmidrosis.
- Design and methods: Patients who visit our hospital and are willing to receive gold microneedle treatment will be randomly divided into the horizontal row movement, vertical row movement and mixed movement pattern groups. A disposable sterile gold microneedle treatment head will be installed, and different parameters will be set according to the elasticity of the patient's underarm skin and the thickness of subcutaneous fat. The entire radiofrequency treatment area will be covered using horizontal row movement, vertical row movement and mixed movement patterns respectively. All three groups will be closely followed up after the operation; during each follow-up, patients will be required to perform the same exercise load as before the operation to evaluate the therapeutic effect and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| transverse needling group | Experimental | Procedure: received transverse needlingreceived transverse needling |
| vertical needling group | Experimental | Procedure: received vertical needlingreceived vertical needling |
| mixed needling group | Experimental | Procedure: received mixed needlingreceived mixed needling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| received transverse needlingreceived transverse needling of high-frequency microneedles | Procedure or surgery | transverse needling group |
| received vertical needlingreceived vertical needling of high-frequency microneedles | Procedure or surgery | vertical needling group |
| received mixed needlingreceived mixed needling of high-frequency microneedles | Procedure or surgery | mixed needling group |
Primary outcome
cure rate
Time frame: 6 months
2 secondary outcomes
effective rate
Time frame: 6 months
recurrece rate
Time frame: 6 months
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 30 Jul 2025.
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 received transverse needling, received vertical needling and received mixed needling in people with Axillary Hyperhidrosis, run by First Affiliated Hospital of Chongqing Medical University 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?
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 30 Jul 2025. 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?
cure rate (time frame: 6 months). 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 30 Jul 2025.