UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062395 |
|---|---|
| Receipt number | R000071375 |
| Scientific Title | Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/29 22:31:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis
Acronym
Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis
Scientific Title
Real-World Safety and Exploratory Effectiveness of Adjunctive Use of a Japanese Quasi-Drug Skin Lotion, Product A, in Patients with Atopic Dermatitis
Scientific Title:Acronym
Real-world Evaluation of Adjunctive Lotion use in Atopic Dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the real-world safety of adjunctive use of Product, which is classified as a quasi-drug under the Pharmaceuticals and Medical Devices Act of Japan, as well as changes in skin condition, pruritus, and related outcome measures, in patients with atopic dermatitis receiving standard treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the Eczema Area and Severity Index (EASI) score from baseline to Week 24
Key secondary outcomes
1. Change from baseline in the Eczema Area and Severity Index (EASI) score at Weeks 4, 8, 12, and 24
2. Change from baseline in the pruritus Numerical Rating Scale (NRS) score at Weeks 4, 8, 12, and 24
3. Change from baseline in serum thymus and activation-regulated chemokine (TARC) levels at Weeks 4, 8, 12, and 24
4. Change from baseline in total serum immunoglobulin E (IgE) levels at Weeks 4, 8, 12, and 24
5. Proportion of participants experiencing adverse events
6. Proportion of participants requiring initiation of rescue treatment and proportion requiring modification of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Product A will be used for 6 months in this study. Participants will apply the product uniformly to the face, trunk, and extremities twice daily, in the morning and after bathing. The recommended amount per application will be 0.4 mL/kg body weight; for example, a participant weighing 50 kg will use approximately 20 mL per application.
Interventions/Control_2
Standard-treatment continuation group without Product A
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older with atopic dermatitis
2. Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
1. Patients with a concomitant skin infection at the time of enrollment that is considered likely to materially affect study assessments
2. Patients whose topical treatment for atopic dermatitis has been substantially changed within 2 weeks before enrollment
3. Patients in whom systemic treatment for atopic dermatitis, including systemic corticosteroids, immunosuppressants, biologic agents, or Janus kinase (JAK) inhibitors, has been initiated or increased in dose within 4 weeks before enrollment
4. Patients scheduled to initiate or increase the dose of any of the above systemic treatments during the study period
5. Patients with a history of hypersensitivity to any component of Product A
6. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period and are considered unsuitable for participation by the principal investigator or a sub-investigator
7. Patients otherwise considered unsuitable for participation in the study by the principal investigator or a sub-investigator
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Watai |
Organization
Kindai University Faculty of Medicine
Division name
Department of Preventive Medicine and Behavioral Sciences
Zip code
5900197
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
TEL
0722887222
watai@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Watai |
Organization
Kindai University Faculty of Medicine
Division name
Department of Preventive Medicine and Behavioral Sciences
Zip code
5900197
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
TEL
0722887222
Homepage URL
watai@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
Tel
0722887222
watai@med.kindai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
近畿大学病院（大阪府）、湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071375
