UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062773 |
|---|---|
| Receipt number | R000071865 |
| Scientific Title | A Single-Arm Prospective Pilot Study to Evaluate the Safety and User Experience of NAP4 Skin Lotion |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/01 19:45:47 |
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Basic information
Public title
A Study of the Safety and User Experience of NAP4 Skin Lotion
Acronym
NAP4 Lotion Study
Scientific Title
A Single-Arm Prospective Pilot Study to Evaluate the Safety and User Experience of NAP4 Skin Lotion
Scientific Title:Acronym
NAP4 Safety and Usability Pilot Study
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to exploratorily evaluate the safety and user experience of NAP4 skin lotion during 4 weeks of use in adult patients with atopic dermatitis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of participants who experience skin adverse events for which a causal relationship with NAP4 skin lotion cannot be excluded during the 4-week treatment period.
Key secondary outcomes
1.Type, frequency, and severity of all adverse events occurring during the use of NAP4 skin lotion.
2.Questionnaire-based assessment of user experience, including ease of application, stickiness, irritation, moisturizing effect, and willingness to continue use.
3.Changes in skin symptoms from baseline to the end of the 4-week treatment period.
4.Proportion of participants who complete the 4-week use of NAP4 skin lotion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will topically apply NAP4 skin lotion containing arginine aminophosphonobutyrate for 4 weeks. Safety and user experience during the intervention period will be evaluated.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 20 years or older at the time of enrollment.
2. Patients who are receiving outpatient care at our Department of Dermatology and have been diagnosed with atopic dermatitis.
3. Individuals who have received sufficient explanation of the study and have provided written informed consent of their own free will.
4. Individuals who are able to complete the questionnaires during the study period and undergo assessments at baseline and 4 weeks.
Key exclusion criteria
1. Individuals with a history of contact dermatitis or similar adverse skin reactions caused by any component of the investigational product or similar ingredients.
2. Individuals with an active severe skin infection at the study site at the time of study initiation.
3. Individuals who have started or changed any new topical or systemic treatment considered likely to affect the study assessments within 2 weeks before study initiation.
4. Individuals who are considered unlikely to complete follow-up through the 4-week assessment.
5. Pregnant or breastfeeding individuals for whom the principal investigator determines that particular caution is required from a safety assessment perspective.
6. Any other individuals whom the principal investigator considers unsuitable for participation in the study for safety reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yutaka |
| Middle name | |
| Last name | inaba |
Organization
wakayama medical university
Division name
dermatology
Zip code
6410012
Address
811-1 kimiidera wakayama
TEL
0734410661
ptfjk298@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | koki |
| Middle name | |
| Last name | kayama |
Organization
wakayama medical university
Division name
dermatology
Zip code
6410012
Address
811-1 kimiidera wakayama
TEL
0734410661
Homepage URL
kkayama@wakayama-med.ac.jp
Sponsor or person
Institute
wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
wakayama medical university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
wakayama medical university
Address
811-1 kimiidera wakayama
Tel
0734410661
ptfjk298@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071865
