Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris

September 3, 2017 updated by: Chang Xie, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris: A Randomized Controlled Trial

This trial is designed to evaluate the efficacy of different frequencies in treating the moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear point tapping.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Acne vulgaris is a common skin disease, especially in adolescents and young adults. Acne affects approximately 85% of teenagers, but can occur in most age groups and can persist into adulthood. There is no mortality associated with acne, but there is often significant physical and psychological morbidity. Acupuncture combined with moving cupping and ear point tapping may effectively relieve the skin lesions, but the evidence is limited. Also, young patients usually have no time to see the doctor frequently, thus it's necessary to figure out a better frequency of treating.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chang Xie, Bachelor
  • Phone Number: +86 13261958032
  • Email: craby616@163.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed as acne vulgaris.
  • GAGS score between 19 and 38 points.
  • Age of 15 to 35 years.

Exclusion Criteria:

  • Other types of acne: acne conglobate, acne fulminans，acne medicamentosa, premenstrual acne，cosmetic acne and trade acne.

  • Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or thyroid diseases, or atypical congenital adrenal hyperplasia；or by any medication prescribed for the treatment of the systemic diseases.

    -- Use of any topical acne treatment or systemic antibiotics or traditional Chinese medicine within 2 weeks before study initiation. Use of a systemic retinoid within 9 months before study initiation. Use of a systemic steroid within 9 months before study initiation. Presence of any change in the use of oral contraceptive pills or anti-inflammatory drugs within 3 months before study initiation.

  • Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea.
  • Presence of severe heart, liver, kidney or hematopoietic system diseases, as well as severe malnutrition.
  • Pregnancy or lactation.
  • Recent use of this research scheme within 4 weeks before study initiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 times per week therapeutic frequency

1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.

  • Huatuo Brand needle (0.20*13mm) will be used for GV14, BL13, ST2, BL2, ST7, ST6 and ashi point on the face. Huatuo Brand needle (0.3*40mm) will be used for GV20, LU5, LI11 and LI4.

    2.Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.

  • Guoyiyan Brand cupping jar (size 4) will be used. 3.Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).
  • Huatuo Brand, made by the seed of Vaccaria segetalis ( Neck.)Garcke.
Procedure: 3 times per week therapeutic frequency
Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.
Active Comparator: 1 time per week therapeutic frequency

The acupoints and treating procedures will be the same as the 3 times per week group. Only treating frequency is different. The treating frequency is 1 time per week.

  1. Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
  2. Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.

  3. Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).

    • Use the seed of Vaccaria segetalis ( Neck.)Garcke.
Procedure: 1 time per week therapeutic frequency
Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IGA success rate
Time Frame: Baseline, week 1-6
The proportion of subjects who achieved at least a two-point reduction from baseline to week 6 in IGA(Investigator's Global Assessment, scale from 0 to 5) score
Baseline, week 1-6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of IGA (Investigator's Global Assessment) score from baseline
Time Frame: Baseline, week 6, week 18, week 30
After 6 weeks treating, the IGA(Investigator's Global Assessment, scale from 0 to 5) score's change from baseline.
Baseline, week 6, week 18, week 30
The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline
Time Frame: Baseline, week 6, week 18, week 30
VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no itch, and 100 mm represents unbearable itch. Patients will rate the VAS (average VAS of facial itch in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of itch over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
Baseline, week 6, week 18, week 30
The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.
Time Frame: Baseline, week 6, week 18, week 30
Visual Analogue Scale (VAS)VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of facial pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of pain over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
Baseline, week 6, week 18, week 30
The change of the Total Lesion Count (TLC) on the face from baseline.
Time Frame: Baseline, week 6, week 18, week 30
TLC is the sum of the inflammatory and non-inflammatory counts, including comedones, papules and pustules, nodules and cysts.
Baseline, week 6, week 18, week 30
The change of the Inflammatory Lesions (IN) on the face from baseline.
Time Frame: Baseline, week 6, week 18, week 30
IN is the sum of papules, pustules, nodules and cysts.
Baseline, week 6, week 18, week 30
The change of the Skindex-16 dermatologic survey score from baseline.
Time Frame: Baseline, week 6, week 18, week 30
Skindex-16 is a dermatologic quality-of-life survey. There are 16 questions in this survey. It concerns the skin condition which has bothered the patient the most during the past week. This survey calculated from 3 aspects including symptoms, emotions and functions. The score of each question is 0 to 6 points, and multiply by 16.6667，and get the sum of 16 questions' score. The average of the sum of 16 questions' score is the final result of skindex-16 dermatology survey. When the score is higher, it means the disease has greater influence on the patient.
Baseline, week 6, week 18, week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GAMHospital20170301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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