UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038645
Receipt number 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 2020/05/22 18:37:14

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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 or person

Institute

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

Institute

Department

Personal name



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

33

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

Completed

Date of protocol fixation

2019 Year 10 Month 15 Day

Date of IRB

2020 Year 02 Month 07 Day

Anticipated trial start date

2020 Year 02 Month 27 Day

Last follow-up date

2020 Year 04 Month 28 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

2020 Year 05 Month 22 Day



Link to view the page

Value
https://center6.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