UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050157 |
|---|---|
| Receipt number | R000057130 |
| Scientific Title | A human clinical study on the protective effect of the test food against ultraviolet-induced skin irritation |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2023/08/29 09:20:02 |
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Basic information
Public title
A human clinical study on the protective effect of the test food against ultraviolet-induced skin irritation
Acronym
A human clinical study on the protective effect of the test food against ultraviolet-induced skin irritation
Scientific Title
A human clinical study on the protective effect of the test food against ultraviolet-induced skin irritation
Scientific Title:Acronym
A human clinical study on the protective effect of the test food against ultraviolet-induced skin irritation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to assess the effect of the test food ingested for 5 weeks on ultraviolet (UV) radiation-induced skin redness and pigmentation in healthy men and women between 30 and 59 years of age.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimal Erythema Dose
Key secondary outcomes
(Secondary outcomes)
L* value (at the site irradiated with 1.5 MED as well as the difference between the non-irradiated site and the site irradiated with 1.5 MED), amount of melanin (at the site irradiated with 1.5 MED as well as the difference between the non-irradiated site and the site irradiated with 1.5 MED)
(Safety endpoints)
Vital signs, physical measurements(body weight and BMI),adverse events
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food for 5 weeks
Interventions/Control_2
Continuous intake of control foods for 5 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are between 30 and 59 years of age at the time of written informed consent.
2.Subjects with Fitzpatrick skin phototype II or III (a skin phototype characterized by burning and then tanning after sunbathing for 30 to 45 minutes during the spring or summer).
3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Key exclusion criteria
1.Subjects diagnosed with photosensitivity by a physician.
2.Subjects receiving medication or outpatient treatment for a serious disease.
3.Subjects receiving exercise or diet therapy under the supervision of a physician.
4.Subjects who maybe for allergic reactions to the material of the test food.
5.Subjects with current or previous history of drug dependence or alcohol dependence.
6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
7.Night or shift workers with irregular life patterns.
8.Subjects whose eating, sleeping, and other habits are extremely irregular.
9.Subjects who are having a very unbalanced diet.
10.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
11.Subjects who use for the site of UV irradiation (the back) or take an anti-inflammatory agent for the skin (topical or oral agent) once a month or more frequently.
12.Subjects who have any factors on the skin of the site of UV irradiation (the back) that may affect the results of the study (disorders such as atopic dermatitis and urticaria, inflammation, eczema, traumatic injury, acne, pimple, wart, spot, tattoo, or other similar conditions or scars of such conditions).
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga, Setagaya-ku, Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2023 | Year | 01 | Month | 27 | 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
90
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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 19 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 04 | Day |
Other
Other related information
(Exclusion criteria continued)
13.Subjects who have used for the site of UV irradiation (the back) or orally taken any products for skin application or food products, including drugs, quasi-drugs, cosmetics, health foods, and supplements, that claim or emphasize its skin-whitening effect, sunburn-preventing effect, or improvement of skin quality (effect of preventing/improving spots, preventing/improving skin damage, or promoting skin cell turnover)within 3 months before the date of informed consent and are unable to stop using/taking such products during the study.
14.Subjects who have been exposed to UV light beyond normal daily activities, by, for example, working outdoors for a long period of time, exercise, sea bathing, or tanning salon, during the 2 months before screening.
15.Subjects who are currently receiving care at an esthetic salon, esthetic treatment (e.g., laser treatment), or physician-supervised esthetic therapy (e.g., Zo Skin Health) for the site of UV irradiation (the back).
16.Subjects who plan to undergo epilation at the site of UV irradiation (the back) during the study.
17.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
18.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
19.Subjects who have difficulty complying with recording of each survey form.
20.Subjects whose laboratory test values or measurements at screening indicate their ineligibility to participate in the study.
21.Other Subjects who are considered ineligible for participation in the study by the investigator.
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057130
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