UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034739
Receipt number 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 2023/05/08 10:17:04

* 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

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 or person

Institute

Nagoya University-MENARD Collaborative Research Chair Nagoya University Graduate school of medicine

Institute

Department

Personal name



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

20

Results

First stage: Questionnaire was conducted.Based on the questionnaire, a hand cream suitable for nurses was prepared.

Results date posted

2023 Year 05 Month 08 Day

Results Delayed


Results Delay Reason

Testing delayed due to COVID-19 infestation.

Date of the first journal publication of results

2023 Year 05 Month 08 Day

Baseline Characteristics

Hospital nurse

Participant flow


Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 01 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2025 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

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.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