UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046159 |
|---|---|
| Receipt number | R000052688 |
| Scientific Title | Study on the evaluation of anti-inflammation and anti-pigmentation effect of the P2 lotion after UV irradiation. |
| Date of disclosure of the study information | 2021/12/14 |
| Last modified on | 2022/05/31 12:15:34 |
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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
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
Igarashi.Sachiyo@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052688
