UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015391 |
|---|---|
| Receipt number | R000017479 |
| Scientific Title | Skin irritation study using SR-0379 (Patch test) |
| Date of disclosure of the study information | 2014/10/21 |
| Last modified on | 2015/01/26 08:15:06 |
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Basic information
Public title
Skin irritation study using SR-0379 (Patch test)
Acronym
Patch test using SR-0379
Scientific Title
Skin irritation study using SR-0379 (Patch test)
Scientific Title:Acronym
Patch test using SR-0379
Region
| Japan |
Condition
Condition
Healthy men
Classification by specialty
| Geriatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patch test (skin irritation test) is planning to examine the safety of SR-0379 (0, 0.02, 0.1, 0.25, 0.5%) in healthy men.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation by skin irritation score at pre-treatment, 1 or 24 hours after treatment (48 hour closed patch test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fifteen microL of SR-0379 (0, 0.02, 0.1, 0.25, 0.5%) is used for 48 hours closed patch test.
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Age: 20-40 years
2) BMI: 18.5-25.0
3) No abnormality in ECG and Blood pressure (under SBP 140mmHg and DBP 90mmHg)
4) Permission by doctors
5) Agreement of patients
Key exclusion criteria
1) drug allergy
2) atopy or tape-sensitive skin
3) inflammation, dermatitis or injury etc. in back skin
4) Burn or tatoo in the back skin
5) history of tape-sensitive dermatitis
6) other severe disease history (liver, kidney, lung and blood diseases)
7) heart failure and ischemic heart disease, and history of these diseases
8) history of heavy alcohol drunker or drug user
9) the patients who cannot stop alcohol or smoking during clinical trial
10) the patients with blood donation (400 mL for 90 days or 200 mL for 14 days)
11) the patients with drug usage for 14 days
12) the patients who attend other clinical trial for 90 days
13) the patients with the abnormal findings in blood immune response and urinary test
14) inappropriate patients judged by doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Takeshi |
Organization
Medical Corporation Shinanokai, Shinanozaka Clinic
Division name
Hospital Director
Zip code
Address
Yotsuya Medhical Building 3F, 20 Samoncho, Shinjuku, Tokyo
TEL
03-5366-3006
hi-nezu@trcp.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisaya Ogura |
Organization
Medical Corporation Shinanokai, Shinanozaka Clinic
Division name
Management office
Zip code
Address
Yotsuya Medhical Building 3F, 20 Samoncho, Shinjuku, Tokyo
TEL
03-5366-3006
Homepage URL
h-ogura@trcp.co.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | Month | 21 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017479
