Atopic Dermatitis (AD)Phase 3NCT05650320
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD
A Phase 3 study testing 0.3% OPA-15406 Ointment and 1% OPA-15406 Ointment in people with Atopic Dermatitis (AD), run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- 0.3% OPA-15406 Ointment and 1% OPA-15406 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to 15 Jan 2025
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
- Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
- Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).
Who cannot join
- 1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
Read the detailed description
- Screening period is defined as the interval between the day of obtaining informed consent and the day of the baseline visit (0-30 days). The investigator performs a screening examination after obtaining informed consent from the subject's legal guardian (and, if possible, after obtaining consent from the subject).
- Assessment period (4 weeks double blind treatment period) is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at the baseline visit will be assigned to receive 0.3% or 1% OPA-15406 ointment or comparator (vehicle [Placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of the Week 4 visit, a withdrawal visit will be performed for that subject.
- Trial period(4 weeks double blind Treatment) The trial period for an individual subject is the period from the day of obtaining the written informed consent from the subject's legal guardian to the day of the Week 4 visit or withdrawal visit. For subjects who miss the Week 4 visit or withdrawal visit, the termination date, will be the date, as determined by the investigator, when the subject is withdrawn from the trial. The trial period does not include a follow-up period for AE.
- 24 weeks, Open label, long term treatment period To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 0.3% or 1% OPA-15406 open treatment for up to 24 weeks based on the inform consent of the subjects.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment, 0% OPA-15406 vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% OPA-15406 OintmentDrug
Twice-daily administration for 4 weeks.
1% OPA-15406 OintmentDrug
Twice-daily administration for 4 weeks.
0% OPA-15406 vehicleOther
Twice-daily administration for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0.3% OPA-15406 Ointment | Experimental | The 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. Receives: Drug: 0.3% OPA-15406 Ointment |
| 1% OPA-15406 Ointment | Experimental | The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. Receives: Drug: 1% OPA-15406 Ointment |
| 0% OPA-15406 Vehicle | Placebo comparator | The 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. Receives: Other: 0% OPA-15406 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in Investigator's Global Assessment at Week 4
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades from baseline. Subjects with missing Investigator's Global Assessmen data will be handled as non-responders.
Measured: 4 weeks
Secondary outcomes (18)
Change from baseline in Investigator's Global Assessment at Week 4
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the change from baseline in Investigator's Global Assessment at Week 4.
Measured: 4 weeks
Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.
Measured: 4 weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4.
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) at Week 4.
Measured: 4 weeks
Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) and at Week 4.
Measured: 4 weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4.
Measured: 4 weeks
Change from baseline in Verbal Rating Scale for Pruritus at Week 4
The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in Verbal Rating Scale for Pruritus at Week 4
Measured: 4 weeks
Change from baseline in Verbal Rating Scale for pruritus up to Day 7
The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's/subjects' judgment.
The efficacy is assessed by Change from baseline in Verbal Rating Scale for Pruritus up to day 7.
Measured: 7 Days
Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Measured: 4 Weeks
Change from baseline in the total affected Body Surface Area (percent) at Week 4
The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 4.
Measured: 4 weeks
Success rate in Investigator's Global Assessment
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades.
Measured: 24 Weeks
Time to Investigator's Global Assessment response
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by time to Investigator's Global Assessment response (Investigator's Global Assessment score of 0 or 1, with improvement by at least 2 grades).
Measured: Within 24 Weeks
Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index)
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index).
Measured: 24 Weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index)
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index).
Measured: 24 Weeks
Success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index)
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index).
Measured: 24 Weeks
Change from baseline in Investigator's Global Assessment
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the change from baseline in Investigator's Global Assessment.
Measured: 24 Weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score.
Measured: 24 Weeks
Change from baseline in the total score of Patient-Oriented Eczema Measure
Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure.
Measured: 24 Weeks
Change from baseline in the total affected Body Surface Area (percent)
The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent).
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start17 Feb 2023
- Primary completion21 Jul 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Ma, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650320
- Sponsor's protocol ID
- 271-403-00013
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2022
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05650320
- Acronym / sponsor ID
- 271-403-00013
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 14 Dec 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.
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
Detailed description
- Screening period is defined as the interval between the day of obtaining informed consent and the day of the baseline visit (0-30 days). The investigator performs a screening examination after obtaining informed consent from the subject's legal guardian (and, if possible, after obtaining consent from the subject).
- Assessment period (4 weeks double blind treatment period) is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at the baseline visit will be assigned to receive 0.3% or 1% OPA-15406 ointment or comparator (vehicle [Placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of the Week 4 visit, a withdrawal visit will be performed for that subject.
- Trial period(4 weeks double blind Treatment) The trial period for an individual subject is the period from the day of obtaining the written informed consent from the subject's legal guardian to the day of the Week 4 visit or withdrawal visit. For subjects who miss the Week 4 visit or withdrawal visit, the termination date, will be the date, as determined by the investigator, when the subject is withdrawn from the trial. The trial period does not include a follow-up period for AE.
- 24 weeks, Open label, long term treatment period To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 0.3% or 1% OPA-15406 open treatment for up to 24 weeks based on the inform consent of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.3% OPA-15406 Ointment | Experimental | Drug: 0.3% OPA-15406 OintmentThe 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
| 1% OPA-15406 Ointment | Experimental | Drug: 1% OPA-15406 OintmentThe 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
| 0% OPA-15406 Vehicle | Placebo comparator | Other: 0% OPA-15406 vehicleThe 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
- Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
- Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).
Key exclusion criteria (1 listed)
- 1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
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 |
|---|---|---|
| 0.3% OPA-15406 OintmentTwice-daily administration for 4 weeks. | Drug | 0.3% OPA-15406 Ointment |
| 1% OPA-15406 OintmentTwice-daily administration for 4 weeks. | Drug | 1% OPA-15406 Ointment |
| 0% OPA-15406 vehicleTwice-daily administration for 4 weeks. | Other | 0% OPA-15406 Vehicle |
Primary outcome
Success rate in Investigator's Global Assessment at Week 4
Time frame: 4 weeks
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades from baseline. Subjects with missing Investigator's Global Assessmen data will be handled as non-responders.
18 secondary outcomes
Change from baseline in Investigator's Global Assessment at Week 4
Time frame: 4 weeks
Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.
Time frame: 4 weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4.
Time frame: 4 weeks
Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4
Time frame: 4 weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4
Time frame: 4 weeks
Change from baseline in Verbal Rating Scale for Pruritus at Week 4
Time frame: 4 weeks
Change from baseline in Verbal Rating Scale for pruritus up to Day 7
Time frame: 7 Days
Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Time frame: 4 Weeks
Change from baseline in the total affected Body Surface Area (percent) at Week 4
Time frame: 4 weeks
Success rate in Investigator's Global Assessment
Time frame: 24 Weeks
Time to Investigator's Global Assessment response
Time frame: Within 24 Weeks
Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index)
Time frame: 24 Weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index)
Time frame: 24 Weeks
Success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index)
Time frame: 24 Weeks
Change from baseline in Investigator's Global Assessment
Time frame: 24 Weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score
Time frame: 24 Weeks
Change from baseline in the total score of Patient-Oriented Eczema Measure
Time frame: 24 Weeks
Change from baseline in the total affected Body Surface Area (percent)
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
Lin Ma principal investigator
Beijing Children's Hospital
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 0.3% OPA-15406 Ointment and 1% OPA-15406 Ointment in people with Atopic Dermatitis (AD), run by Otsuka Beijing Research Institute 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate in Investigator's Global Assessment at Week 4 (time frame: 4 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 25 Mar 2025.