- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348978
Auricular Acupressure Combined With Adapalene for the Treatment of Acne Vulgaris
Efficacy of Auricular Acupressure Combined With 0.1% Adapalene in the Treatment of Acne Vulgaris
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ho Chi Minh City
-
Ho Chi Minh City, Ho Chi Minh City, Vietnam
- Le Van Thinh Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Auricular Acupressure Plus Adapalene
Participants received auricular acupressure combined with topical 0.1% adapalene.
|
Auricular acupressure was performed by applying pressure to specific auricular points according to traditional medicine principles.
The intervention was administered as an adjunctive therapy in combination with topical adapalene.
Other Names:
Topical adapalene 0.1% was applied to affected areas once daily as standard treatment for acne vulgaris.
|
|
Experimental: Active Comparator
Participants received topical 0.1% adapalene alone.
|
Topical adapalene 0.1% was applied to affected areas once daily as standard treatment for acne vulgaris.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Global Acne Grading System (GAGS) score
Time Frame: 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.
|
From baseline to week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in inflammatory and non-inflammatory acne lesion counts
Time Frame: From baseline to week 4
|
The number of inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) was recorded at baseline and weekly during treatment. The secondary outcome was the change in lesion counts from baseline to week 4 between the two treatment groups. |
From baseline to week 4
|
|
Change in Dermatology Life Quality Index (DLQI) score
Time Frame: From baseline to week 4
|
Quality of life was assessed using the Dermatology Life Quality Index (DLQI), a validated questionnaire consisting of 10 items. The secondary outcome was the change in DLQI score from baseline to week 4, comparing the two study groups. |
From baseline to week 4
|
|
Incidence of treatment-related adverse events
Time Frame: During the 4-week treatment period
|
Adverse events were monitored throughout the study period, including skin dryness, burning sensation, itching, erythema, and other local or systemic reactions. The frequency and type of adverse events were recorded and compared between groups. |
During the 4-week treatment period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bay Thi Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Study Director: Huy Chung Ly, University of Medicine and Pharmacy at Ho Chi Minh City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Skin and Connective Tissue Diseases
- Acne Vulgaris
- Organic Chemicals
- Pharmaceutical Preparations
- Dosage Forms
- Hydrocarbons
- Hydrocarbons, Cyclic
- Naphthalenes
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Complex Mixtures
- Colloids
- Adapalene
- Gels
Other Study ID Numbers
- 2464-DHYD-HDDD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
-
Ghurki Trust and Teaching HospitalCompletedAcne Vulgaris | Acne Vulgaris on the FacePakistan
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.Active, not recruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.RecruitingInflammatory Acne VulgarisUnited States
Clinical Trials on Auricular Acupressure
-
Guangdong Provincial Hospital of Traditional Chinese...Completed
-
Beijing Tongren HospitalNot yet recruitingEmergence AgitationChina
-
Johns Hopkins UniversityTerminatedChemotherapy-induced Peripheral Neuropathy (CIPN)United States
-
University of Medicine and Pharmacy at Ho Chi Minh...CompletedTemperature Change, BodyVietnam
-
Chang-Hua HospitalChina Medical University HospitalUnknownInsomnia | Anxiety | Menopause | Auricular AcupressureTaiwan
-
The First Affiliated Hospital of Zhejiang Chinese...RecruitingFunctional Dyspepsia | Insomnia | Brain and Nervous SystemChina
-
Heilongjiang University of Chinese MedicineUnknownPolycystic Ovary SyndromeChina
-
University of ChicagoRecruitingFrailty | Lobectomy | Segmentectomy | Prehabilitation | Thoracic | Lung Surgery | Wedge Resection | Pneumonectomy; StatusUnited States
-
Cathay General HospitalNational Taipei University of Nursing and Health SciencesRecruitingPost-stroke Depression | Auricular AcupressureTaiwan
-
Bui Pham Minh ManCompletedHealthy VolunteersVietnam