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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034739
Receipt No. R000039346
Scientific Title Standard decision of hand cream specialized in a healthcare professionals
Date of disclosure of the study information 2019/05/31
Last modified on 2019/04/25

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Basic information
Public title Standard decision of hand cream specialized in a healthcare professionals
Acronym Standard decision of hand cream specialized in a healthcare professionals
Scientific Title Standard decision of hand cream specialized in a healthcare professionals
Scientific Title:Acronym Standard decision of hand cream specialized in a healthcare professionals
Region
Japan

Condition
Condition Prevention and amelioration for rough hands
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aim to clarify the needs for skin external preparation which satisfy medical professionals. For this purpose, we will send inquiries about their conditions of rough hands, when and how often they care their hands, and what they need for hand creams, etc. We will set a standard that satisfy the request specifications to develop a hand cream that can prevent and ameliorate rough hands of medical professionals, which we believe also contributes to improvement of their quality of life, prevention of infection and infection spread in medical settings.
Basic objectives2 Others
Basic objectives -Others We attempt to set specifications of hand creams which medical professionals require.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will perform a 4-week clinical study using an optimized hand cream preparation, and will evaluate the skin conditions and the satisfaction of the subjects before and after the use of the cream. As a primary outcome, the water content of the stratum corneum will be measured before and after the use of the hand cream preparation.
Key secondary outcomes As secondary outcomes, conditions of the skin and other aspects of hands and fingers as follows will be observed before and after the use of the hand cream preparation: epidermal turnover, skin surface shape, elasticity, softness, blood flow rate, and skin color.

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 Prevention
Type of intervention
Other
Interventions/Control_1 We will perform a 4-week clinical study using an optimized hand cream preparation, and evaluate the skin conditions and the satisfaction of the subjects before and after the use of the cream.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Those who understand the purpose of this study and voluntarily agree to participate it. The consent to the participation must be demonstrated in a written consent form.
Key exclusion criteria 1. Systemic treatment with steroids.
2. Systemic treatment with cyclosporin.
3. Current treatment on hands.
4. Exudative changes on a test area, with the stratum corneum severely damaged.
5. Skin problems on a test area which may affect the study result, such as inflammation, eczema, injury, acne, eruption and wart.
6. A history of allergy or suspected to have allergies to cosmetic or food products (including skin problems such as rashes caused by the contact of cosmetics within a year prior to the study ).
7. Have received a special skin care (such as aesthetic treatment in a beauty salon) within 4 weeks prior to the clinical study , or plan to receive during the study.
8. Patients with a serious abnormality in sugar metabolism, lipid metabolism, liver function, renal function, the cardiovascular system, the respiratory system, the endocrine system, the immune system or the nervous system, or with a history of neurological diseases.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Hasegawa
Organization Nagoya University Graduate school of medicine
Division name Nagoya University-MENARD Collaborative Research Chair
Zip code 466-8550
Address 65 Tsrumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2350
Email hasegawa.seiji@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Hasegawa
Organization Nagoya University Graduate school of medicine
Division name Nagoya University-MENARD Collaborative Research Chair
Zip code 466-8550
Address 65 Tsrumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2350
Homepage URL
Email hasegawa.seiji@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University-MENARD Collaborative Research Chair Nagoya University Graduate school of medicine
Institute
Department

Funding Source
Organization Nagoya University-MENARD Collaborative Research Chair Nagoya University Graduate school of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Nagoya University Graduate School of Medicine
Address 65 Tsrumai-cho, Showa-ku, Nagoya
Tel 052-744-2973
Email ethics@med.nagoya-u.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
2019 Year 05 Month 31 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039346

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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