Acne VulgarisPhase 3NCT05035979
Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris
A Phase 3 study testing BaidI Quzhi granule and Ju Yin cream in people with Acne Vulgaris, run by Shanghai Yueyang Integrated Medicine Hospital.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BaidI Quzhi granule and Ju Yin cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- BaidI Quzhi granule, Ju Yin cream, Baidi Quzhi placebo granule, Ju Yin placebo cream
- Keywords
- Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaidI Quzhi granuleDrug
Also called Chinese Herbal Medicine
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 creamDrug
Also called Chinese Herbal Medicine
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 granuleDrug
Also called Chinese Herbal Medicine
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 creamDrug
Also called Chinese Herbal Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| TCM comprehensive treatment group | Experimental | 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. Receives: Drug: BaidI Quzhi granule; Drug: Ju Yin cream |
| TCM internal treatment group | Active comparator | 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. Receives: Drug: BaidI Quzhi granule; Drug: Ju Yin placebo cream |
| TCM external treatment group | Active comparator | 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. Receives: Drug: Ju Yin cream; Drug: Baidi Quzhi placebo granule |
| Placebo group | Placebo comparator | 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. Receives: Drug: Baidi Quzhi placebo granule; Drug: Ju Yin placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 16th weeks
Secondary outcomes (8)
skin lesion count (total, inflammatory and non-inflammatory)
The change level of the investigators' overall assessment(IGA) score
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Patients will be evaluated at Baseline and at the 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study chair, Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035979
- Sponsor's protocol ID
- 2020045
- Status last verified
- Aug 2021
- First submitted
- 13 Jun 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05035979
- Acronym / sponsor ID
- 2020045
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TCM comprehensive treatment group | Experimental | Drug: BaidI Quzhi granule, Drug: Ju Yin creamParticipants 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 | Active comparator | Drug: BaidI Quzhi granule, Drug: Ju Yin placebo creamParticipants 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 | Active comparator | Drug: Ju Yin cream, Drug: Baidi Quzhi placebo granuleParticipants 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 | Placebo comparator | Drug: Baidi Quzhi placebo granule, Drug: Ju Yin placebo creamParticipants 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaidI Quzhi granuleAlso: Chinese Herbal MedicinePut 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. | Drug | TCM comprehensive treatment group, TCM internal treatment group |
| Ju Yin creamAlso: Chinese Herbal MedicineTake 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. | Drug | TCM comprehensive treatment group, TCM external treatment group |
| Baidi Quzhi placebo granuleAlso: Chinese Herbal MedicinePut 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. | Drug | Placebo group, TCM external treatment group |
| Ju Yin placebo creamAlso: Chinese Herbal MedicineTake 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. | Drug | Placebo group, TCM internal treatment group |
Primary outcome
Success rate of the investigators' overall assessment (IGA) for acne vulgaris
Time frame: 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.
8 secondary outcomes
skin lesion count (total, inflammatory and non-inflammatory)
Time frame: 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
Time frame: 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
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Skindex-16 scale
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Traditional Chinese Medicine(TCM) syndrome score
Time frame: Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Interleukin(IL)-17
Time frame: Patients will be evaluated at Baseline and at the 8th week.
25-hydroxy Vitamin D
Time frame: Patients will be evaluated at Baseline and at the 8th week.
Dehydroepiandrosterone-sulfate(DHEA-S)
Time frame: Patients will be evaluated at Baseline and at the 8th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Zhou study chair
Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BaidI Quzhi granule and Ju Yin cream in people with Acne Vulgaris, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Li (0086-0021-55981301, 18930568129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the investigators' overall assessment (IGA) for acne vulgaris (time frame: up to 16th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.