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临床试验/NCT07348978
NCT07348978已完成不适用

Efficacy of Auricular Acupressure Combined With 0.1% Adapalene in the Treatment of Acne Vulgaris

University of Medicine and Pharmacy at Ho Chi Minh City1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Change in Global Acne Grading System (GAGS) score

研究概览

简要总结

Acne vulgaris is a common chronic inflammatory skin condition that can significantly affect quality of life. Standard treatments such as topical retinoids are effective but may not fully control symptoms in all patients.

This study evaluated the effectiveness of auricular acupressure combined with topical 0.1% adapalene compared with topical 0.1% adapalene alone in patients with acne vulgaris. Auricular acupressure is a non-invasive traditional medicine technique that may help regulate inflammatory responses and improve skin conditions.

The objective of this study was to determine whether the combination therapy provides greater improvement in acne severity and clinical outcomes than standard topical treatment alone.

详细描述

Acne vulgaris is a multifactorial inflammatory skin disease commonly affecting adolescents and young adults. Although topical retinoids such as adapalene are widely used and effective, some patients experience incomplete responses or persistent symptoms.

Auricular acupressure is a traditional therapeutic method that involves stimulating specific points on the ear and has been used to support systemic regulation and inflammatory control. This study was designed to explore the potential added benefit of auricular acupressure when combined with standard topical adapalene therapy.

This interventional study compared two treatment approaches in patients with acne vulgaris: auricular acupressure combined with topical 0.1% adapalene versus topical 0.1% adapalene alone. Participants were assigned to treatment groups according to the study protocol and followed for clinical assessment.

The primary objective of the study was to evaluate the effectiveness of the combination therapy in improving acne severity and overall clinical outcomes compared with standard treatment alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients aged 18 to 35 years.
  • Clinical diagnosis of mild to moderate acne vulgaris based on the Global Acne Grading System (GAGS).
  • Willingness to comply with the study protocol and attend all scheduled visits.
  • Provided written informed consent prior to participation.

排除标准

  • Severe acne vulgaris requiring systemic treatment.
  • Use of systemic acne treatments (such as isotretinoin, antibiotics, or hormonal therapy) within the past 4 weeks.
  • Use of topical acne treatments within 2 weeks prior to enrollment.
  • Presence of other dermatological conditions that may interfere with evaluation.
  • Pregnancy or breastfeeding.
  • Known allergy or hypersensitivity to adapalene or components of the intervention.

研究组 & 干预措施

Auricular Acupressure Plus Adapalene

Experimental

Participants received auricular acupressure combined with topical 0.1% adapalene.

干预措施: Auricular Acupressure (Other)

Auricular Acupressure Plus Adapalene

Experimental

Participants received auricular acupressure combined with topical 0.1% adapalene.

干预措施: Adapalene 0.1% Gel (Drug)

Active Comparator

Experimental

Participants received topical 0.1% adapalene alone.

干预措施: Adapalene 0.1% Gel (Drug)

结局指标

主要结局

Change in Global Acne Grading System (GAGS) score

时间窗: From baseline to week 4

The Global Acne Grading System (GAGS) was used to assess acne severity. The total GAGS score was calculated at baseline and at the end of treatment. The primary outcome was the change in GAGS score from baseline to the end of treatment, and comparisons were made between the two study groups.

次要结局

  • Change in inflammatory and non-inflammatory acne lesion counts(From baseline to week 4)
  • Change in Dermatology Life Quality Index (DLQI) score(From baseline to week 4)
  • Incidence of treatment-related adverse events(During the 4-week treatment period)

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Trang Le Thi Ha

Medical Doctor

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (1)

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