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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027664
Receipt No. R000031348
Scientific Title Examination of the usefulness of new dosage forms for external preparation (frothiness sprays) of the heparin similar material agent
Date of disclosure of the study information 2017/06/09
Last modified on 2019/03/29

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Basic information
Public title Examination of the usefulness of new dosage forms for external preparation (frothiness sprays) of the heparin similar material agent
Acronym Usefulness examination of the Form Spray
Scientific Title Examination of the usefulness of new dosage forms for external preparation (frothiness sprays) of the heparin similar material agent
Scientific Title:Acronym Usefulness examination of the Form Spray
Region
Japan

Condition
Condition dry skin
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the usefulness of new dosage forms for external preparation (frothiness sprays) on the patient with the skin drying symptom
Basic objectives2 Others
Basic objectives -Others impression from use
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of change of the water content in epidermal stratum corneum of 4 weeks
Key secondary outcomes Usability of the patient

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 4 weeks, appropriate amount, appropriately
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
1 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) The patients who it present a skin drying symptom, and are treated for a heparin similar material agent for external preparation.
2) The patients that an agreement were provided in a document after having explained this study contents.
Key exclusion criteria 1) Patients who are treated for an agent for anti-inflammatory external preparation, and they visit a hospital for treatment regularly.
2) Patients with hemorrhagic blood disorder
3) Patient that it are expected that little bleeding causes a serious result.
4) Patients who use a steroid or anti-allergic drug.
5) Patients with a medical history of the serious disease.
6) Patients who have difficulty in patient diary entry.
7) A pregnant woman or the woman who may be pregnant and the woman whom I am nursing. The patient who hopes for the pregnancy during a study period.
8) The patients that the co-investigator judged this study enforcement to be inappropriate.
9) The patients who participate in other clinical trials for the past three months.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kawashima
Organization Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
Division name Department of Dermatology
Zip code
Address 8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email kawashima.makoto@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Ogaki
Organization EBC&M LLC.
Division name Project planning & Development department
Zip code
Address CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
TEL 03-6435-3833
Homepage URL
Email yoshitaka_ogaki@ebc-m.com

Sponsor
Institute Non-Profit Organization Health Institute Research of Skin
Institute
Department

Funding Source
Organization Nippon Zoki Pharmaceutical 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
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
2017 Year 06 Month 09 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
2017 Year 03 Month 27 Day
Date of IRB
2017 Year 04 Month 04 Day
Anticipated trial start date
2017 Year 04 Month 12 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2017 Year 06 Month 05 Day
Date analysis concluded
2017 Year 06 Month 19 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 06 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031348

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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