Comparison of the Clinical Efficacy and Adverse Reactions of Different Needling Patterns of High-frequency Microneedles in the Treatment of Axillary Odor (NCT07094009)

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Study 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. 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.

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Conditions studied

Axillary Hyperhidrosis

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In context

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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

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Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 90 participants (actual)

Study arms

Experimental
transverse needling group
received transverse needling
Procedure: received transverse needling
Experimental
vertical needling group
received vertical needling
Procedure: received vertical needling
Experimental
mixed needling group
received mixed needling
Procedure: received mixed needling

Interventions

Procedurereceived transverse needling
received transverse needling of high-frequency microneedles
Procedurereceived vertical needling
received vertical needling of high-frequency microneedles
Procedurereceived mixed needling
received mixed needling of high-frequency microneedles

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What researchers measure

Primary outcomes

cure rate
Time frame: 6 months

Secondary outcomes

effective rate
Time frame: 6 months
recurrece rate
Time frame: 6 months

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Study locations

1 site

the First Affiliated Hospital of Chongqing Medical Uiversity
Chongqing, Chongqing Municipality 400016, China

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT07094009
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Responsible party: Chengcheng Shen (Attending Physician of Dermatology, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted: Jul 30, 2025
Start date: Oct 18, 2023
Primary completion: Apr 1, 2025
Completion: Apr 1, 2025
Last update: Jul 30, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Comparison of the Clinical Efficacy and Adverse Reactions of Different Needling Patterns of High-frequency Microneedles in the Treatment of Axillary Odor

From the registry’s dates