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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038645
Receipt No. R000044033
Scientific Title Randomized, placebo-controlled, double-blind, split-face comparative study on the skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/20

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Basic information
Public title Study on the skin improvement effects of the cosmetic containing collagen-modified liposomes
Acronym KNO-001 study
Scientific Title Randomized, placebo-controlled, double-blind, split-face comparative study on the skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing
Scientific Title:Acronym KNO-001 study
Region
Japan

Condition
Condition Healthy adult women scheduled to complete skin laser treatment
Classification by specialty
Aesthetic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Skin improvement effects of the cosmetic containing collagen-modified liposomes after wounds healing, and other skin effects including safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of skin moisture (test site):
Evaluation is made before application of the test product or placebo, 1 week, 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
Key secondary outcomes Skin moisture measurement (1 cheek site of each split face)
Evaluation of skin findings by doctors
Analysis of changes in skin conditions using digital camera images
Participant questionnaire
Incidence of adverse events

Skin moisture measurement and analysis of digital camera images are evaluated before application of the test product or placebo, 1 week, 2 weeks, 4 weeks, and 6 weeks after application of the test product or placebo.
The skin findings are evaluated 1 week, 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
The questionnaire for the participants will be evaluated 2 weeks, 4 weeks and 6 weeks after the start of application of the test product or placebo.
In addition, safety will be checked throughout the period.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the test product (skin cosmetic containing a cosmetic base consisting of collagen-modified liposomes) twice a day, and apply an appropriate amount for 6 weeks after wounds healing (after epithelial recovery) following laser treatment.
Interventions/Control_2 Apply the placebo, that is the skin cosmetic from which the constituents of the cosmetic base 'collagen modified liposome' are removed from the test product, twice a day, and apply an appropriate amount for 6 weeks after wounds healing (after epithelial recovery) following laser treatment.
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 Female
Key inclusion criteria (1) Women who can obtain written consent
(2) Women who are between 20 and 60 years old when obtaining consent
(3) Women with laser treatment target sites on both the left and right sides of the face
(4) Women who can go to the hospital according to the study schedule
Key exclusion criteria (1) Persons with histories of allergies to cosmetic
(2) Person receiving any hormone replacement therapies
(3) Pregnant and breastfeeding women
(4) Persons who have experience in cosmetic medicine that affects the evaluation site, or who are scheduled to receive it during the study period
(5) Persons who have undergone special skin care (e.g., beauty salon, esthetic salon) for the evaluation site within the past 4 weeks or who are scheduled to receive it during the study period
(6) Persons with inflammation or skin disease that affects evaluation
(7) Persons who are judged to be inappropriate for participation in this study by the principal investigator or other investigators (hereinafter referred to as the investigators)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Takeda
Organization Kitasato University, school of medicine
Division name Department of Plastic & Aesthetic Surgery
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa
TEL 042-778-9074
Email takeda@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Sugimoto
Organization Kitasato University, school of medicine
Division name Department of Plastic & Aesthetic Surgery
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa
TEL 042-778-9074
Homepage URL
Email yoshika_sgy@yahoo.co.jp

Sponsor
Institute Kitasato University, school of medicine,
Department of Plastic & Aesthetic Surgery
Institute
Department

Funding Source
Organization Faith 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 Kitasato University, school of medicine, Institutional Review Board for Clinical Research and Treatment
Address 1-15-1Kitasato,Minami-ku,Sagamihara-city,Kanagawa
Tel 042-778-8111
Email rinrib@med.kitasato-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 北里大学病院(神奈川県)/ Kitasato University Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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
2019 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 07 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
2019 Year 11 Month 20 Day
Last modified on
2019 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044033

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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