UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055805 |
|---|---|
| Receipt number | R000063781 |
| Scientific Title | A randomized, comparative study of adhesion to skin between two firm dressings in healthy participants |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2024/10/11 11:18:21 |
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Basic information
Public title
A study of adhesion to skin for film dressings
Acronym
A study of adhesion to skin for film dressings
Scientific Title
A randomized, comparative study of adhesion to skin between two firm dressings in healthy participants
Scientific Title:Acronym
A randomized, comparative study of adhesion to skin between two firm dressings in healthy participants
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the adhesion of two film dressings on the forearm skin of healthy participants over a 4-day application period.
Basic objectives2
Others
Basic objectives -Others
Adhesion to the skin
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adhesion to the skin after 4 days of dermal application
Key secondary outcomes
Adhesion, itchiness, pain, skin maceration, adhesive residue, skin reaction
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
| Device,equipment |
Interventions/Control_1
Right forearm: Dressing A
Left forearm: Dressing B
Interventions/Control_2
Right forearm: Dressing B
Left forearm: Dressing 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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese female and male participants who were aged 20 to 49 years
2. Healthy aprticipants who has no history of outpatient visits or medication for disease treatment
3. Participants who have healthy skin
4. Participats who are able to provide informed consent
5. Participats who are able to shave forearm hair with a T-shaped razor, if necessary.
Key exclusion criteria
1. Participants who have a history of previous treatment applied to the skin, particularly within the previous 2 weeks
2. Participants who have a history of anaphylactoid symptoms
3. Participants who have a history of hypersensitivity symptoms when applying a skin dressing or bandage
4. Participants who have a current history of atopic dermatitis
5. Participants who have a skin symptoms such as wounds or eczema on the forearm
6. Participants who have excessive hairiness on the forearm.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takemasa |
| Middle name | |
| Last name | Kokubo |
Organization
NICHIBAN CO., LTD.
Division name
Quality Assurance
Zip code
112-8663
Address
2-3-3 SEKIGUCHI, BUNKYO-KU, TOKYO, 112-8663, JAPAN
TEL
03-5978-5089
t-kokubo@nichiban.co.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Sakurai |
Organization
NICHIBAN CO., LTD.
Division name
Medical Regulatory Affairs
Zip code
112-8663
Address
2-3-3 SEKIGUCHI, BUNKYO-KU, TOKYO, 112-8663, JAPAN
TEL
03-5978-5089
Homepage URL
shio-murayama@nichiban.co.jp
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NICHIBAN CO., LTD.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 10 | Month | 11 | 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
26
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063781
