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

Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: BaidI Quzhi granule; Drug: Ju Yin cream; Drug: Ju Yin placebo cream; Drug: Baidi Quzhi placebo granule

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 Type: Interventional
• Enrollment (Anticipated): 472
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bin Li; Phone Number: 0086-0021-55981301; Email: 18930568129@163.com
• Study Contact Backup: Name: Li Ju; Phone Number: 0086-0021-65161782; Email: 1090622414@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCM comprehensive treatment group; 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.	Drug: BaidI 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.; Other Names: Chinese Herbal Medicine; Drug: Ju 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.; Other Names: Chinese Herbal Medicine
Active Comparator: TCM internal treatment group; 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.	Drug: BaidI 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.; Other Names: Chinese Herbal Medicine; Drug: Ju 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.; Other Names: Chinese Herbal Medicine
Active Comparator: TCM external treatment group; 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.	Drug: Ju 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.; Other Names: Chinese Herbal Medicine; Drug: Baidi 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.; Other Names: Chinese Herbal Medicine
Placebo Comparator: Placebo group; 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.	Drug: Ju 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.; Other Names: Chinese Herbal Medicine; Drug: Baidi 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.; Other Names: Chinese Herbal Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 16th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin lesion count (total, inflammatory and non-inflammatory)	The change level of the investigators' overall assessment(IGA) score	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.	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.	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	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	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.	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	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	Patients will be evaluated at Baseline and at the 8th week.

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborators: Shanghai Skin Disease and Venereal Disease Hospital
• Investigators: Study Chair: Jia Zhou, Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Traditional Chinese Medicine; Acne Vulgaris; BaiDI QuZhi granule; Ju YIn cream
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 2020045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No