UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039625
Receipt No. 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 (Ver. 1)

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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
Institute Kao Corporation
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045195