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

NCT07094009 | Completed

• 1 other identifier: 2023-435
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• cure rate

  6 months

Secondary Outcomes (2)

• effective rate

  6 months

• recurrece rate

  6 months

Study Arms (3)

transverse needling group

EXPERIMENTAL

received transverse needling

Procedure: received transverse needling

vertical needling group

EXPERIMENTAL

received vertical needling

Procedure: received vertical needling

mixed needling group

EXPERIMENTAL

received mixed needling

Procedure: received mixed needling

Interventions

received transverse needling PROCEDURE

received transverse needling of high-frequency microneedles

transverse needling group

received vertical needling PROCEDURE

received vertical needling of high-frequency microneedles

vertical needling group

received mixed needling PROCEDURE

received mixed needling of high-frequency microneedles

mixed needling group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical Uiversity

Chongqing, Chongqing Municipality, 400016, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Dermatology

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: October 18, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (1)