UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039625
Receipt number R000045195
Scientific Title Before-after study of the efficacy of Contact Needle Therapy (CNT) on skin appearances and physiological properties.
Date of disclosure of the study information 2020/04/01
Last modified on 2020/02/28 11:13:56

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Basic information

Public title

Efficacy test of CNT for skin.

Acronym

Efficacy test of CNT for skin.

Scientific Title

Before-after study of the efficacy of Contact Needle Therapy (CNT) on skin appearances and physiological properties.

Scientific Title:Acronym

Efficacy test of CNT for skin.

Region

Japan


Condition

Condition

Healthy females

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm cosmetic and physiological efficacy of CNT for the facial skin of healthy female.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The improvement of the perceived skin texture evaluated by respondents between before and after CNT.

Key secondary outcomes

Evaluation of the water content of stratum corneum, morphological feature of vessel, blood flow and the 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

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the CNT for skin around cheek area.

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

50 years-old >=

Gender

Female

Key inclusion criteria

Healthy females

Key exclusion criteria

-Subjects with trouble on facial skin like atopic dermatitis, eczema and pollen allergy.
-Currently, subjects who are in the dermatology department or regularly visited. Expectant and nursing women.
-Subjects who have a history of allergies to cosmetics.
-Subjects who participate in other tests.
-Subjects who live irregular lives.
-Subjects who have unstable menstrual cycles.
-Subjects deemed inappropriate to participate in this study by the principle investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoshito
Middle name
Last name Takahashi

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

250-0002

Address

5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN

TEL

+81-465-34-6116

Email

takahashi.yoshito@kao.com


Public contact

Name of contact person

1st name Keiichi
Middle name
Last name Sugata

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

250-0002

Address

5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN

TEL

+81-465-34-6116

Homepage URL


Email

sugata.keiichi@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kanazawa University Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com


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

花王株式会社(神奈川県)


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 01 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

20

Results

Significant improvements were shown for the perceived skin texture evaluated by respondents. A significant increase in skin moisture was observed. Number of blood vessels observed using microscope increased.

Results date posted

2020 Year 02 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy females

Participant flow

Apply the CNT for skin around cheek area.

Adverse events

None

Outcome measures

skin texture

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 26 Day

Date of IRB

2016 Year 10 Month 26 Day

Anticipated trial start date

2016 Year 10 Month 26 Day

Last follow-up date

2016 Year 12 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 02 Month 28 Day

Last modified on

2020 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045195


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name