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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015391
Receipt No. 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

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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
Email 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
Email h-ogura@trcp.co.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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