Clinical trial NCT05035979: Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris
Official title: Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Randomized controlled trial
BaiDI QuZhi granule
Ju YIn cream
Traditional Chinese Medicine
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Skin Disease and Venereal Disease Hospital
First posted: 2021-09-05
Enrollment: 472
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of the investigators' overall assessment (IGA) for acne vulgaris
timeFrame: up to 16th weeks
Secondary outcomes:
measure: skin lesion count (total, inflammatory and non-inflammatory)
timeFrame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
measure: Visual analogue scale (VAS) score of facial itching symptoms
timeFrame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
measure: Visual analogue scale(VAS) score of facial pain symptoms
timeFrame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
measure: Skindex-16 scale
timeFrame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
measure: Traditional Chinese Medicine(TCM) syndrome score
timeFrame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
measure: Interleukin(IL)-17
timeFrame: Patients will be evaluated at Baseline and at the 8th week.
measure: 25-hydroxy Vitamin D
timeFrame: Patients will be evaluated at Baseline and at the 8th week.
measure: Dehydroepiandrosterone-sulfate(DHEA-S)
timeFrame: Patients will be evaluated at Baseline and at the 8th week.
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References: