Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris

Phase 3

• Conditions: Acne Vulgaris
• Interventions: Drug: BaidI Quzhi granule; Drug: Ju Yin cream; Drug: Ju Yin placebo cream; Drug: Baidi Quzhi placebo granule

• Registration Number: NCT05035979
• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-13
• Status Verified: 2021-08
• Study First Submitted QC: 2021-09-03
• Last Update Submitted: 2021-09-03
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-12-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 472

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM comprehensive treatment group	BaidI Quzhi granule	Participants in the TCM treatment group will receive BaiDi Quzhi granule two times daily after meals, Ju Yin cream therapy three times per week for 8 weeks.
TCM comprehensive treatment group	Ju Yin cream	Participants in the TCM treatment group will receive BaiDi Quzhi granule two times daily after meals, Ju Yin cream therapy three times per week for 8 weeks.
TCM internal treatment group	BaidI Quzhi granule	Participants in the TCM internal treatment group will receive Baidi Quzhi granule two times daily after meals and Ju Yin placebo therapy three times per week for 8 weeks.
TCM internal treatment group	Ju Yin placebo cream	Participants in the TCM internal treatment group will receive Baidi Quzhi granule two times daily after meals and Ju Yin placebo therapy three times per week for 8 weeks.
TCM external treatment group	Ju Yin cream	Participants in the TCM external treatment group will receive Baidi Quzhi placebo granule two times daily after meals and Ju Yin cream therapy three times per week for 8 weeks.
TCM external treatment group	Baidi Quzhi placebo granule	Participants in the TCM external treatment group will receive Baidi Quzhi placebo granule two times daily after meals and Ju Yin cream therapy three times per week for 8 weeks.
Placebo group	Baidi Quzhi placebo granule	Participants in the placebo group will receive Baidi Quzhi placebo granule two times daily after meals, Ju Yin placebo therapy three times per week for 8 weeks.
Placebo group	Ju Yin placebo cream	Participants in the placebo group will receive Baidi Quzhi placebo granule two times daily after meals, Ju Yin placebo therapy three times per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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