UMIN-CTR Clinical Trial

Basic information
Public title	The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Acronym	The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Scientific Title	The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Scientific Title:Acronym	The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Region	Japan

Condition
Condition	Severe wrinkles around eyes
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study of effect for wrinkles around eyes when used topical nanoencapsulation retinol combination cosmetic
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire and observation for skin condition on before study starting and 4 weeks and 8 weeks after study starting
Key secondary outcomes	Investigating of VISIA, skin viscoelasticity, TEWL, erythema, water content in the corneal layer, and replica of wrinkles around eyes on before study starting and 4 weeks and 8 weeks after study starting

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants 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	Application of the test cosmetic A to the one side of the face, Application of the test cosmetic B to the another side of the face, 8 weeks, twice a day
Interventions/Control_2	Application of the test cosmetic C to the one side of the face, Application of the test cosmetic D to the another side of the face, 8 weeks, twice a day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 6 to 7 wrincle grade in eye area 2) Individuals who can visit to clinic (Japanese males and females) 3) Individuals providing written informed consent 4) Individuals not younger than 20 years old at the time of informed consent
Key exclusion criteria	1) Individuals who are sensitive to test product 2) Individuals who are or are possibly pregnant, or are lactating 3) Individuals with severe skin diseases 4) Individuals without capacity to consent 5) Individuals judged inappropriate for the study by a doctor
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Yamaguchi
Organization	Nanoegg Research Laboratories, Inc.
Division name	Pharmaceutical Products Research and Development Section
Zip code	210-0821
Address	Innovation Center of NanoMedicine 4F, 3-2514 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL	044-400-1155
Email	rdm@nanoegg.co.jp

Public contact
Name of contact person	1st name Yoshiki Middle name Last name Kubota
Organization	Nanoegg Research Laboratories, Inc.
Division name	Pharmaceutical Products Research and Development Section
Zip code	210-0821
Address	Innovation Center of NanoMedicine 4F, 3-2514 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL	044-400-1155
Homepage URL
Email	rdm@nanoegg.co.jp

Sponsor
Institute	Nanoegg Research Laboratories, Inc.
Institute
Department

Funding Source
Organization	Nanoegg Research Laboratories, 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	Institutional Review Board for the Asai Dermatology Clinic
Address	RBM Kyobashi building, 3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel	03-5543-0196
Email	aya.onoda@smo-msr.co.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	医療法人社団美翔会　聖心美容クリニック　熱海院（静岡県）

Other administrative information
Date of disclosure of the study information	2020 Year 09 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	1
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	Terminated
Date of protocol fixation	2020 Year 08 Month 05 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2022 Year 08 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 08 Month 25 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047341