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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.
Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGIGA 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
Time frame: Baseline, week 1-6
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.
Time frame: Baseline, week 6, week 18, week 30
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.
Time frame: Baseline, week 6, week 18, week 30
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.
Time frame: Baseline, week 6, week 18, week 30
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.
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Time frame: Baseline, week 6, week 18, week 30
The change of the Inflammatory Lesions (IN) on the face from baseline.
IN is the sum of papules, pustules, nodules and cysts.
Time frame: Baseline, week 6, week 18, week 30
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.
Time frame: Baseline, week 6, week 18, week 30