NCT03264287

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

August 9, 2017

Last Update Submit

September 3, 2017

Conditions

Acne Vulgaris

Keywords

acne vulgarisacupuncturecuppingear point tappingrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • IGA success rate

    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 Outcomes (6)

  • The change of IGA (Investigator's Global Assessment) score from baseline

    Baseline, week 6, week 18, week 30

  • The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline

    Baseline, week 6, week 18, week 30

  • The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.

    Baseline, week 6, week 18, week 30

  • The change of the Total Lesion Count (TLC) on the face from baseline.

    Baseline, week 6, week 18, week 30

  • The change of the Inflammatory Lesions (IN) on the face from baseline.

    Baseline, week 6, week 18, week 30

  • +1 more secondary outcomes

Study Arms (2)

3 times per week therapeutic frequency

EXPERIMENTAL

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

1 time per week therapeutic frequency

ACTIVE COMPARATOR

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

Interventions

3 times per week therapeutic frequencyPROCEDURE

Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.

3 times per week therapeutic frequency
1 time per week therapeutic frequencyPROCEDURE

Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.

1 time per week therapeutic frequency

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (5)

  • Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.

    PMID: 9248884BACKGROUND

  • Song BH, Lee DH, Kim BC, Ku SH, Park EJ, Kwon IH, Kim KH, Kim KJ. Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study. J Am Acad Dermatol. 2014 Oct;71(4):764-71. doi: 10.1016/j.jaad.2014.05.047. Epub 2014 Jun 12.

    PMID: 24930587BACKGROUND

  • Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.

    PMID: 26897386BACKGROUND

  • Jung JY, Hong JS, Ahn CH, Yoon JY, Kwon HH, Suh DH. Prospective randomized controlled clinical and histopathological study of acne vulgaris treated with dual mode of quasi-long pulse and Q-switched 1064-nm Nd:YAG laser assisted with a topically applied carbon suspension. J Am Acad Dermatol. 2012 Apr;66(4):626-33. doi: 10.1016/j.jaad.2011.08.031. Epub 2011 Oct 26.

    PMID: 22033354BACKGROUND

  • Eichenfield LF, Jarratt M, Schlessinger J, Kempers S, Manna V, Hwa J, Liu Y, Graeber M; Adapalene Lotion Study Group. Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2010 Jun;9(6):639-46.

    PMID: 20645525BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Central Study Contacts

Chang Xie, Bachelor

CONTACT

+86 13261958032craby616@163.com

Zhishun Liu, Doctor

CONTACT

010-88002331liuzhishun@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student of Beijing University of Chinese Medicine & Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 29, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 30, 2020

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

CN(1)