Atopic Dermatitis (AD)Phase 3NCT07184645
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
A Phase 3 study testing OPA-15406 in people with Atopic Dermatitis (AD), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD) Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- OPA-15406
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
- Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
- Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Who cannot join
- Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
- Participants who have been treated with OPA-15406 ointment in the past
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drug Information Center contact
About this study
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- 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.
OPA-15406Drug
Also called difamilast
0.3% foam or 1% foam, topical, twice daily, for 8 weeks
VehicleDrug
vehicle, topical, twice daily, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| OPA-15406 foam | Experimental | Not described Receives: Drug: OPA-15406 |
| Vehicle | Experimental | Not described Receives: Drug: 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 (IGA)
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184645
- Sponsor's protocol ID
- 271-102-00044
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 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 Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)
- ClinicalTrials.gov ID
- NCT07184645
- Acronym / sponsor ID
- 271-102-00044
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPA-15406 foam | Experimental | Drug: OPA-15406 |
| Vehicle | Experimental | Drug: Vehicle |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
- Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
- Participants with an IGA score of 2 or 3 at the screening and baseline examinations
Key exclusion criteria (2 listed)
- Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
- Participants who have been treated with OPA-15406 ointment in the past
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 |
|---|---|---|
| OPA-15406Also: difamilast0.3% foam or 1% foam, topical, twice daily, for 8 weeks | Drug | OPA-15406 foam |
| Vehiclevehicle, topical, twice daily, for 8 weeks | Drug | Vehicle |
Primary outcome
Success rate in Investigator's Global Assessment (IGA)
Time frame: Week 4
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of participants whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
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.
Drug Information Center contact
Nobuhito Sanada study director
Otsuka Pharmaceutical Co., Ltd.
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 OPA-15406 in people with Atopic Dermatitis (AD), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 2 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: opening soon, as of the sponsor's last update on 22 Sep 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 Japan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Drug Information Center (+81-3-6361-7314), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate in Investigator's Global Assessment (IGA) (time frame: Week 4). 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 22 Sep 2025.