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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264287
• Other study ID #: GAMHospital20170301
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: September 3, 2017
• Start date: September 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Chang Xie, Bachelor
• Phone: +86 13261958032
• Email: craby616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of IGA (Investigator's Global Assessment) score from baseline	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
Secondary	The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline	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
Secondary	The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.	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
Secondary	The change of the Total Lesion Count (TLC) on the face from baseline.	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
Secondary	The change of the Inflammatory Lesions (IN) on the face from baseline.	IN is the sum of papules, pustules, nodules and cysts.	Baseline, week 6, week 18, week 30
Secondary	The change of the Skindex-16 dermatologic survey score from baseline.	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