UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025686
Receipt No. R000029549
Scientific Title Use test of moisturizer for patients with atopic dermatitis and patients receiving EGFR inhibitor-nonrandomized/nonblinded-
Date of disclosure of the study information 2017/01/15
Last modified on 2019/03/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Use test of moisturizer for patients with atopic dermatitis and patients receiving EGFR inhibitor-nonrandomized/nonblinded-
Acronym Use test of moisturizer for patients with atopic dermatitis and patients receiving EGFR inhibitor
Scientific Title Use test of moisturizer for patients with atopic dermatitis and patients receiving EGFR inhibitor-nonrandomized/nonblinded-
Scientific Title:Acronym Use test of moisturizer for patients with atopic dermatitis and patients receiving EGFR inhibitor
Region
Japan

Condition
Condition atopic dermatitis, psoriasis, Patient receiving EGFR inhibitor
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A moisturizing agent developed for dry skin was applied to a patient suffering from dry symptoms of the skin such as atopic dermatitis, psoriasis and the like and a patient exhibiting dry symptoms of the skin by administration of EGFR inhibitor and dried Examine the moisturizing effect on sexual skin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of skin dryness (skin findings)
Drying scores before and after the test at each observation site have changed by 1 or more
Key secondary outcomes Skin physiological verification (changes in skin measurement value and cytokine in epidermal horny layer)
Changes in stratum corneum water content, epidermal water transpiration amount, IL-1a, TARC, TSLP
Improvement of QOL and feeling of use of this research product by questionnaire
Changes in the subscales (functions, symptoms, emotions, comprehensive) of Skindex - 16 which is a skin disease specific scale and feeling of use feeling (feeling of moisture, stickiness, etc.) of the questionnaire

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Use the test moisturizer in combination with treatment.
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 Male and Female
Key inclusion criteria ・Patients with skin disorders such as atopic dermatitis, psoriasis or the like, or patients with dry symptoms of the skin by EGFR inhibitor administration
・Those who are judged to be expected to improve dry skin symptoms due to the use of this research item
・The treatment of the original disease is not restricted
・There is no problem in terms of age and gender (including children)
・After receiving sufficient explanation for participation in this research, after sufficient understanding, the patient himself (a substitute in the case of a minor, but the principal and the substitute person over the age of 16 is free) by the free will Patient who got written consent
Key exclusion criteria ・Person who experienced skin symptoms such as contact dermatitis due to the ingredients of this research item and similar ingredients
・Persons who have skin lesions etc. that are inappropriate for the application of this research item at the application site
・Persons who can not be examined after 8 weeks (in principle)
・pregnancy and lactating
・In addition, patients who the research staff judged inappropriate as subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Iwata
Organization Hokkaido University Hospital
Division name Dermatology
Zip code 060-0814
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-716-1161
Email hiriwata0927@yahoo.co.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Iwata
Organization Hokkaido University Hospital
Division name Dermatology
Zip code 060-0814
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email hiriwata0927@yahoo.co.jp

Sponsor
Institute Hokkaido University Hospital
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 Hokkaido University Hospital Certified Review Board
Address Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido 060-8648, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

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 01 Month 15 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 20
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 01 Month 16 Day
Date of IRB
2017 Year 01 Month 16 Day
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 15 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029549

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.