UMIN-CTR Clinical Trial

Basic information
Public title	Study on the evaluation of anti-inflammation and anti-pigmentation effect of the P2 lotion after UV irradiation.
Acronym	Study on the evaluation of anti-inflammation and anti-pigmentation effect of the P2 lotion after UV irradiation.
Scientific Title	Study on the evaluation of anti-inflammation and anti-pigmentation effect of the P2 lotion after UV irradiation.
Scientific Title:Acronym	Study on the evaluation of anti-inflammation and anti-pigmentation effect of the P2 lotion after UV irradiation.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the effect of the lotions on UV induced inflammation and pigmentation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin color (L*, a*, b*), melanin index, erythema index on the target skin area at 0, 1 days and 3, 4 weeks.
Key secondary outcomes

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	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Application of the lotion 1 to the target skin area twice a day (morning and night) for 1 week before UV irradiation and 4 weeks after irradiation.
Interventions/Control_2	Application of the lotion 2 to the target skin area twice a day (morning and night) for 1 week before UV irradiation and 4 weeks after irradiation.
Interventions/Control_3	Application of the lotion 3 to the target skin area twice a day (morning and night) for 1 week before UV irradiation and 4 weeks after irradiation.
Interventions/Control_4	Application of the lotion 4 to the target skin area twice a day (morning and night) for 1 week before UV irradiation and 4 weeks after irradiation.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	1)Subjects whose age at consent day is from 30 to 60 years old 2)Subjects with Fitzpatrick skin type II or III 3)Subjects who are judged to be suitable for this study from the pre-application check by the principle investigator 4)Subjects who are voluntary participation and informed consent
Key exclusion criteria	1)Subjects with photosensitive skin. 2)Subjects who have significant change of skin condition by menstrual cycle. 3)Subjects who take drugs that affect skin photosensitivity. 4)Subjects who have the factors on the target area which may affect this study. 5)Subjects who have got aesthetic medicine on the target area. 6)Subjects who continuously use skin care products or functional foods on the target area which had same or similar effect with the test sample. 7)Subjects who continuously use bath additive, excluding one who can stop using them during this study. 8)Subjects who continuously use moisturizer and/or body cream on the target area, excluding one who can stop using them during this study. 9)Subjects who continuously use drugs which have effect on pigmentation and/or melasma. 10)Subjects with atopic dermatitis, regardless of the area. 11)Subjects who have undergone special skincare treatment at the target area within 4 weeks or during this study. 12)Subjects who have changed and/or started using functional foods and/or sunscreen on the target area within 4 weeks. 13)Subjects who have or will be exposed to excessive UV beyond the daily life during this study. 14)Subjects who are night or shift workers. 15)Subjects who have treated or prevented their disease or need to be treatment in a clinic at the consent 16)Subjects who have serious diseases or medical history including glucose or lipid metabolisms, liver or kidney functions, cardiovascular, respiratory, endocrine or nervous systems. 17)Subjects with a history of alcohol and/or drug addiction. 18)Subjects who have a risk of allergy during this study. 19)Subjects who are pregnant, lactating or hoping to be pregnant during this study. 20)Subjects who participated in the similar study within 6 months. 21)Subjects who have participated or will participate in the other clinical study within 4 weeks. 22)Subjects who are judged as ineligible for participating in this study by the principle investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Sachiyo Middle name Last name Igarashi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Otsu Skin Care Research Institute
Zip code	520-0002
Address	3-31-13 Saigawa, Otsu, Shiga
TEL	077-521-8835
Email	Igarashi.Sachiyo@otsuka.jp

Public contact
Name of contact person	1st name Sachiyo Middle name Last name Igarashi
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Otsu Skin Care Research Institute
Zip code	520-0002
Address	3-31-13 Saigawa, Otsu, Shiga
TEL	077-521-8835
Homepage URL
Email	Igarashi.Sachiyo@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Brain Care Clinic Ethics Review Committee
Address	Shiratori Bldg. 2F, 2-1-2 Shinjuku, Shinjuku, Tokyo
Tel	06-6882-1130
Email	ethics_board@drc-web.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

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 14 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	24
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	2021 Year 09 Month 16 Day
Date of IRB	2021 Year 09 Month 24 Day
Anticipated trial start date	2021 Year 11 Month 02 Day
Last follow-up date	2021 Year 12 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 24 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052688