UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042289
Receipt number R000048279
Scientific Title Safety and efficacy study of lotion
Date of disclosure of the study information 2020/10/30
Last modified on 2021/05/18 12:21:13

* 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

Safety and efficacy study of lotion

Acronym

Safety and efficacy study of lotion

Scientific Title

Safety and efficacy study of lotion

Scientific Title:Acronym

Safety and efficacy study of lotion

Region

Japan


Condition

Condition

Healthy female

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the safety and efficacy of the test material with plant extract by visual evaluation and bioinstrumentation when applying the test material and placebo on the left or right side of face respectively for 21 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hydration level of stratum corneum(0Weeks,13Weeks, and 21Weeks)

Key secondary outcomes

The activities on 0Weeks,13Weeks, and 21Weeks visits are as follows:
Photographs of facial image: VISIA-Evolution (Spots, Brown spots, UV spots, Skintexture, Wrinkles, and Pores)
Visual Evaluations
Wrinkle Grade Evaluations
Photographs of skin image: ANTERA 3D(Spots)
Skin color: Chromameter CM-600d
Skin color index: Mexameter
Trans-epidermal water loss: Vapometer SWL5001JT
Skin Viscoelasticity:Cutometer MPA580
Replicas
Photographic Evaluations (Spots and Wrinkles)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the test material on the left face and placebo on the right face respectively twice a day for 21 weeks.

Interventions/Control_2

Apply the test material on the right face and placebo on the left face respectively twice a day for 21 weeks.

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

40 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

(1) Japanese female aged from 40 to 59 years;
(2) Subject who is willing to participate in the study and can comply with study requirements;
(3) Subject who has any age spots on the left or right side of face;
(4) Subject who has "crow's feet" wrinkles of grade 3 to 6 at the corners of both eyes; and
(5) Subject who dehydrates face skin in winter.

Key exclusion criteria

(1) Subject who is pregnant or nursing, or is planning to become pregnant or nursing during the study;
(2)Subject who used any drug, quasi-drug, or supplements, within 1 month before the baseline visit, that will affect the site to be examined;
(3) Subject who has a skin disorder such as atopic dermatitis;
(4) Subject who will take any skin care medication that may affect the results of the study;
(5) Subject who experienced any cosmetic medication that may affect the results of the study;
(6) Subject who is currently taking hormone replacement therapy;
(7) Subject who is participating in any other clinical trials; and
(8) Subject who otherwise disqualified from participation in the study for any reason at the discretion of the study physician.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Kazumi
Middle name
Last name Nozawa

Organization

Interface, Inc.

Division name

Not applicable

Zip code

010-0001

Address

2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan

TEL

018-827-7155

Email

kazumi.nozawa@interface-akita.com


Public contact

Name of contact person

1st name Miyuki
Middle name
Last name Kodama

Organization

Interface, Inc.

Division name

Not applicable

Zip code

010-0001

Address

2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan

TEL

018-827-7155

Homepage URL


Email

mkodama@interface-akita.com


Sponsor or person

Institute

Interface, Inc.

Institute

Department

Personal name



Funding Source

Organization

Fuji Sangyo, Inc.

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

The ethical committee of Interface, Inc.

Address

2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan

Tel

018-827-7155

Email

mkodama@interface-akita.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



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 30 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

Completed

Date of protocol fixation

2020 Year 10 Month 16 Day

Date of IRB

2020 Year 10 Month 26 Day

Anticipated trial start date

2020 Year 10 Month 30 Day

Last follow-up date

2021 Year 03 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

2020 Year 10 Month 30 Day

Last modified on

2021 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name