We designed the study as a double-blind,randomized,controlled clinical trial.The aim of this trial is to clarify the treatment efficacy, safety, and recurrence control of BaiDi QuZhi(BDQZ) granule combined with Ju Yin(JY) cream in the treatment of acne vulgaris.
Acne is a chronic inflammatory skin disease of hair follicle and sebaceous gland, which is common in adolescents and adults.Systemic drugs commonly used in the treatment of acne include isotretinoin, oral antibiotics and hormone preparations. Isotretinoin is the first choice for the treatment of moderate and severe acne, but its use is limited by its adverse reactions such as cheilitis, elevated blood lipids and teratogenicity .The efficacy of BDQZ granule in the treatment of acne is accurate. However, large-scale randomized controlled trials have not been conducted on the efficacy, safety and recurrence of BDQZ granule. Therefore, our aim was to conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial of oral BDQZ granule combined with JY cream in the treatment of acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
472
Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.
Take JY cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.
Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.
Success rate of the investigators' overall assessment (IGA) for acne vulgaris
On the IGA (0-5) score, the percentage of subjects with IGA score reduction (baseline IGA- week 8 IGA) greater than or equal to 2 points.
Time frame: up to 16th weeks
skin lesion count (total, inflammatory and non-inflammatory)
The change level of the investigators' overall assessment(IGA) score
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Visual analogue scale (VAS) score of facial itching symptoms
VAS are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individiual patients and use this to achieve a rapid classification of symptom and disease control.
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Visual analogue scale(VAS) score of facial pain symptoms
VAS are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individiual patients and use this to achieve a rapid classification of symptom and disease control.
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Skindex-16 scale
A brief Quality-of-Life measure for patients with the skin diseases
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Traditional Chinese Medicine(TCM) syndrome score
Score TCM syndromes such as tongue, pulse and clinical manifestations
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Take JY placebo cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Interleukin(IL)-17
IL-17 was implicated in the pathogenic mechanisms of both inflammatory and infectious skin diseases such as staphylococcus infection, contact hypersensitivity, psoriasis and atopic dermatitis.
Time frame: Patients will be evaluated at Baseline and at the 8th week.
25-hydroxy Vitamin D
Vitamin D deficiency may have a role in the pathogenesis of acne
Time frame: Patients will be evaluated at Baseline and at the 8th week.
Dehydroepiandrosterone-sulfate(DHEA-S)
Adrenal steroid hormones produced by the secretion of the adrenal gland
Time frame: Patients will be evaluated at Baseline and at the 8th week.