Clinical trial NCT03264287: Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris
Official title: Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne vulgaris
acupuncture
cupping
ear point tapping
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: IGA success rate
timeFrame: Baseline, week 1-6
Secondary outcomes:
measure: The change of IGA (Investigator's Global Assessment) score from baseline
timeFrame: Baseline, week 6, week 18, week 30
measure: The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline
timeFrame: Baseline, week 6, week 18, week 30
measure: The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.
timeFrame: Baseline, week 6, week 18, week 30
measure: The change of the Total Lesion Count (TLC) on the face from baseline.
timeFrame: Baseline, week 6, week 18, week 30
measure: The change of the Inflammatory Lesions (IN) on the face from baseline.
timeFrame: Baseline, week 6, week 18, week 30
measure: The change of the Skindex-16 dermatologic survey score from baseline.
timeFrame: Baseline, week 6, week 18, week 30
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References:
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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.