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

NCT ID: NCT07094009

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2025-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

transverse needling group

received transverse needling

Group Type: EXPERIMENTAL

received transverse needling

Intervention Type: PROCEDURE

received transverse needling of high-frequency microneedles

vertical needling group

received vertical needling

Group Type: EXPERIMENTAL

received vertical needling

Intervention Type: PROCEDURE

received vertical needling of high-frequency microneedles

mixed needling group

received mixed needling

Group Type: EXPERIMENTAL

received mixed needling

Intervention Type: PROCEDURE

received mixed needling of high-frequency microneedles

Interventions

received transverse needling

received transverse needling of high-frequency microneedles

Intervention Type: PROCEDURE

received vertical needling

received vertical needling of high-frequency microneedles

Intervention Type: PROCEDURE

received mixed needling

received mixed needling of high-frequency microneedles

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chengcheng Shen

Attending Physician of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital of Chongqing Medical Uiversity

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

2023-435

Identifier Type: -

Identifier Source: org_study_id