Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine
Brief summary
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.
Detailed description
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.
Interventions
DRUGBaidI Quzhi granule
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.
DRUGJu Yin cream
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.
DRUGBaidi Quzhi placebo granule
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.
DRUGJu Yin placebo cream
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.
Sponsors
Shanghai Skin Disease and Venereal Disease Hospital
Shanghai Yueyang Integrated Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
\- 1. Patients with acne vulgaris aged from 16 to 45, male or female. 2. Patients who meet the western diagnostic criteria of mild and moderate acne vulgaris and the differentiation criteria of TCM syndrome (15,16). 3\. Patients who voluntarily join this study with informed consent. 4. No acne drugs were received within 1 month, and no external drugs related to the disease were used within 1 week.
Exclusion criteria
* 1\. Patients with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system. 2\. Participants will be ineligible if they ate pregnant or lactating women, and those with fertility plans in the next 2 years. 3\. Patients who do not meet the inclusion criteria, fail to use the medicine according to the regulations, fail to judge the curative effect, or incomplete data affect the judgment of curative effect or safety. 4\. Allergic constitution and allergic to the drug ingredients studied in this project. 5\. Cicatricial constitution. 6.Occupational acne caused by chemicals, acne caused by drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the investigators' overall assessment (IGA) for acne vulgaris | up to 16th weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) score of facial itching symptoms | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 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. |
| Visual analogue scale(VAS) score of facial pain symptoms | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 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. |
| Skindex-16 scale | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | A brief Quality-of-Life measure for patients with the skin diseases |
| skin lesion count (total, inflammatory and non-inflammatory) | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | The change level of the investigators' overall assessment(IGA) score |
| Interleukin(IL)-17 | Patients will be evaluated at Baseline and at the 8th week. | 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. |
| 25-hydroxy Vitamin D | Patients will be evaluated at Baseline and at the 8th week. | Vitamin D deficiency may have a role in the pathogenesis of acne |
| Dehydroepiandrosterone-sulfate(DHEA-S) | Patients will be evaluated at Baseline and at the 8th week. | Adrenal steroid hormones produced by the secretion of the adrenal gland |
| Traditional Chinese Medicine(TCM) syndrome score | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | Score TCM syndromes such as tongue, pulse and clinical manifestations |
Contacts
Primary ContactBin Li
Backup ContactLi Ju
Outcome results
None listed