Atopic DermatitisPhase 3NCT05326672
Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
A Phase 3 study testing Benvitimod Cream in people with Atopic Dermatitis, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Benvitimod Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
- IGA ≥ 3.
- Capable of giving written informed consent.
Who cannot join
- Skin lesions were limited to head, neck, hands and feet.
- ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.
- Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.
- Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.
- Subjects with malignant neoplasms.
- Subjects with severe comorbid conditions may require systematic hormone therapy or other interventions, affect study participation or require frequent active monitoring (e.g., unstable chronic asthma).
Show all 19Show fewer
- Subjects with definite skin infection with local bacteria, viruses and fungi.
- Subjects with mental illness or other reasons may interfere with participation in the study.
- Known to be allergic to any of the components of the drug.
- Severe hypersensitivity to food, drugs, insect venom, rubber, etc.
- Women who are pregnant, breast-feeding, or planning to become pregnant.
- Alcohol, drug abuse and known drug dependence.
- Prior to enrollment, the following treatments were used within the specified time period:
- External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)
- Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).
- Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).
- Received uv therapy and photochemotherapy within 4 weeks.
- Participated in clinical trials of other drugs or medical devices within 4 weeks.
- The patients who were considered unsuitable to participate in the study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yan Zhao, 18500291610, zhaoyan377@hotmail.com
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks.
Read the detailed description
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA < 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase.
The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 participants recruited form about 20 centers in China.
All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.
- Conditions
- Atopic Dermatitis
- Being tested
- Benvitimod Cream, Placebo
- Keywords
- Benvitimod Cream, Atopic Dermatitis, Topical Treatment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benvitimod CreamDrug
Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
PlaceboDrug
Placebo, applied twice daily for 8 weeks after enrolment.
| Study group | Role | What they receive |
|---|---|---|
| Benvitimod Cream | Experimental | Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment. Receives: Drug: Benvitimod Cream |
| Placebo | Placebo comparator | Placebo, applied twice daily for 8 weeks after enrolment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema and induration as guidelines. Higher IGA scores represent more severe disease.
Measured: Week 8
Secondary outcomes (19)
Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Measured: Week 8
Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Measured: Week 8
Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Measured: Week 8
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Measured: Week 8
Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Measured: Week 8
Overall EASI improvement rate and its changes with time from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Measured: Week 8
The average IGA decrease and its changes with time from Baseline to Week 8
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema and induration as guidelines. Higher IGA scores represent more severe disease.
Measured: Week 8
The average DLQI decrease and its changes with time from Baseline to Week 8
The DLQI is a simple dermatology-specific 10-question validated questionnaire to assess the impact of the disease on a participant's quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Measured: Week 8
The average BSA decrease and its changes with time from Baseline to Week 8
The assessment of %BSA affected is an estimate of the percentage of total involved skin with atopic dermatitis. For the purpose of clinical estimation, the total palmar surface of the participant's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by atopic dermatitis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Measured: Week 8
The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Measured: Week 8
Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Measured: Week 52
Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Measured: Week 52
Incidence of TEAE and SAE
TEAE definition: treatment emergent adverse event.
Measured: Week 52
Number of recurrences in recurrence participants
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Measured: Week 52
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Measured: Week 52
EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
The IGA is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 6-point morphological assessment of overall disease severity, as determined by the investigator, using
Measured: Week 52
Incidence of AE/ADR at each visit during medication
AE definition: adverse event. ADR definition: adverse reaction.
Measured: Week 52
Incidence of SAE and TEAE leading to discontinuation
SAE definition: serious adverse events. TEAE definition: treatment emergent adverse event.
Measured: Week 52
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhonghao Pharmaceutical
- Responsible party
- Principal investigator, Zhang jianzhong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326672
- Sponsor's protocol ID
- TJ-BWMD-2021
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05326672
- Acronym / sponsor ID
- TJ-BWMD-2021
- Conditions
- Atopic Dermatitis
- Keywords
- Benvitimod Cream, Atopic Dermatitis, Topical Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Zhonghao Pharmaceutical
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Apr 2022 (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.
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks.
Detailed description
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with atopic dermatitis for 8 weeks. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA < 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase.
The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 participants recruited form about 20 centers in China.
All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benvitimod Cream | Experimental | Drug: Benvitimod CreamBenvitimod cream, 1%, applied twice daily for 8 weeks after enrolment. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, applied twice daily for 8 weeks after enrolment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
- IGA ≥ 3.
- Capable of giving written informed consent.
Key exclusion criteria (19 listed)
- Skin lesions were limited to head, neck, hands and feet.
- ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.
- Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.
- Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.
- Subjects with malignant neoplasms.
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 |
|---|---|---|
| Benvitimod CreamBenvitimod cream, 1%, applied twice daily for 8 weeks after enrolment. | Drug | Benvitimod Cream |
| PlaceboPlacebo, applied twice daily for 8 weeks after enrolment. | Drug | Placebo |
Primary outcome
Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8
Time frame: Week 8
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema and induration as guidelines. Higher IGA scores represent more severe disease.
19 secondary outcomes
Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Time frame: Week 8
Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Time frame: Week 8
Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Time frame: Week 8
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Time frame: Week 8
Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
Time frame: Week 8
Overall EASI improvement rate and its changes with time from Baseline to Week 8
Time frame: Week 8
The average IGA decrease and its changes with time from Baseline to Week 8
Time frame: Week 8
The average DLQI decrease and its changes with time from Baseline to Week 8
Time frame: Week 8
The average BSA decrease and its changes with time from Baseline to Week 8
Time frame: Week 8
The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
Time frame: Week 8
Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
Time frame: Week 52
Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
Time frame: Week 52
Incidence of TEAE and SAE
Time frame: Week 52
Number of recurrences in recurrence participants
Time frame: Week 52
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
Time frame: Week 52
EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
Time frame: Week 52
Incidence of AE/ADR at each visit during medication
Time frame: Week 52
Incidence of SAE and TEAE leading to discontinuation
Time frame: Week 52
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Time frame: Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benvitimod Cream in people with Atopic Dermatitis, run by Peking University People's Hospital at 1 site in China.
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 4 inclusion and 19 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jianzhong Zhang (010-88325472, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8 (time frame: Week 8). 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 2 May 2022.