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

• 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 Overview

• Status: Completed
• Conditions: Axillary Hyperhidrosis
• Intervention / Treatment: Procedure: received transverse needling; Procedure: received vertical needling; Procedure: received mixed needling

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transverse needling group; received transverse needling	Procedure: received transverse needling; received transverse needling of high-frequency microneedles
Experimental: vertical needling group; received vertical needling	Procedure: received vertical needling; received vertical needling of high-frequency microneedles
Experimental: mixed needling group; received mixed needling	Procedure: received mixed needling; received mixed needling of high-frequency microneedles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cure rate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
effective rate	6 months
recurrece rate	6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: July 23, 2025
• First Submitted That Met QC Criteria: July 23, 2025
• First Posted (Actual): July 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Sweat Gland Diseases; Hyperhidrosis
• Other Study ID Numbers: 2023-435

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No