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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05035979
• Other study ID #: 2020045
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2021
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Bin Li
• Phone: 0086-0021-55981301
• Email: 18930568129[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 472
• Est. completion date: August 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital	Shanghai Skin Disease and Venereal Disease Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.