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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015335
Receipt No. R000017830
Scientific Title Clinical study about a skin disorder patient's skin care(2)
Date of disclosure of the study information 2014/10/30
Last modified on 2016/10/05

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Basic information
Public title Clinical study about a skin disorder patient's skin care(2)
Acronym Clinical study about a skin disorder patient's skin care(2)
Scientific Title Clinical study about a skin disorder patient's skin care(2)
Scientific Title:Acronym Clinical study about a skin disorder patient's skin care(2)
Region
Japan

Condition
Condition A disease patient with atopic dermatitis, psoriasis, old human instinct xerosis, drying of the skin such as contact dermatitides and the pigmentation
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 About an unregulated drug developed as a skin care agent for the disease patient with atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and the pigmentation, I carry out a 12-week use examination. For these skin disease patients, I confirm whether you can use this study product without skin stimulation safely and confirm the improvement degree of the dry symptom of the skin as a preliminary evaluation for the usefulness evaluation examination (drying of the skin and improvement of the pigmentation symptom) for the many cases that I will plan in future.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes I do the period of service of this study product in all target people with same 12 weeks and, at the time of a start, observe the change of the skin symptom at the time of six weeks later and the end in (12 weeks later). But, in the case of harmful phenomenon expression, I continue observation until the disappearance of the symptom.
In addition, the desired evaluation in this study aims for a "security" evaluation of more than 90% in Clause 11.2. In addition, as spare examination to the examination in many cases on the basis of the safe confirmation in this study, I pass through a class of corners fluid volume in approximately the examination and analyze an epidermis water loss quantity, skin of epidermis fat quantity, cytokine concerned with inflammation such as class of corners TARC, shape of the class of corners cell and skin color.
Key secondary outcomes

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 The use part of this study product assumes it face. I list it in an attached sheet document about the usage of each study product (5 preparation) and the instructions. Twice a day (morning, night:) Apply 2 mg/cm2 (with all faces for two pearl grain sizes) to an aim after bathing in), all faces and a neck; for the significant part of the pigmentation more study product (Clause 0.4:) I apply knob lift white whitening stick). In addition, I do not set it during the wash out period in approximately the examination.
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 Female
Key inclusion criteria Among the patients with the symptom of drying of the skin and the pigmentation, I intend for a person meeting the next standard.
・Atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and pigmentation
The person who is judged from the person of the disease with the symptom in the treatment of the underlying disease if the use of this study product is useful
・The person who is stable in its symptom of the underlying disease by treatment
・Woman 20 years or older
・The person that a written agreement is provided from the person
Key exclusion criteria In the case of next, I exclude it from an object.
・Person with the experience that produced the skin symptoms such as contact dermatitides by this study product ingredient and similar ingredient
・Person with the exanthem that is unsuitable for the application of this study product in the application part
・The person who is not stable in its symptom of the underlying disease
・A man and woman younger than 20 years
・The person whom (as a general rule) cannot examine 12 weeks later
・Person of pregnancy and nursing
・In addition, the person that an examination responsibility (allotment) doctor judges the participation in this study to be inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Graduate School of Medicine.
Division name Department of Dermatology
Zip code
Address 1-1seiryo-cho aoba-ku sendai
TEL 022-717-7271
Email kkikuchi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Graduate School of Medicine.
Division name Department of Dermatology
Zip code
Address 1-1seiryo-cho aoba-ku sendai
TEL 022-717-7271
Homepage URL
Email kkikuchi@med.tohoku.ac.jp

Sponsor
Institute Department of Dermatology
Tohoku University Graduate School of Medicine.
Institute
Department

Funding Source
Organization TOKIWA 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
2014 Year 10 Month 30 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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
2015 Year 09 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 03 Day
Last modified on
2016 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017830

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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