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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Chang Xie, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Chang Xie, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT03264287
First received: August 9, 2017
Last updated: September 3, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Acne Vulgaris Procedure: 3 times per week therapeutic frequency Procedure: 1 time per week therapeutic frequency

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chang Xie, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 100
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: December 30, 2020
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03264287

Contacts
Contact: Chang Xie, Bachelor +86 13261958032 craby616@163.com
Contact: Zhishun Liu, Doctor 010-88002331 liuzhishun@aliyun.com

Locations
China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Chang Xie, Bachelor    +86 13261958032    craby616@163.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  More Information

Publications:

Responsible Party: Chang Xie, Postgraduate student of Beijing University of Chinese Medicine & Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03264287     History of Changes
Other Study ID Numbers: GAMHospital20170301
Study First Received: August 9, 2017
Last Updated: September 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Xie, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
acne vulgaris
acupuncture
cupping
ear point tapping
randomized controlled trial

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on September 21, 2017