UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049199 |
|---|---|
| Receipt number | R000056038 |
| Scientific Title | A study on the effect of SNR16 intake during the follicular phase on skin condition -A Randomized, Open-Label, No Intake Controlled, Crossover Study- |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2023/09/08 09:17:07 |
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Basic information
Public title
A study on the effect of SNR16 intake during the follicular phase on skin condition
Acronym
A study on the effect of SNR16 intake during the follicular phase on skin condition
Scientific Title
A study on the effect of SNR16 intake during the follicular phase on skin condition
-A Randomized, Open-Label, No Intake Controlled, Crossover Study-
Scientific Title:Acronym
A study on the effect of SNR16 intake during the follicular phase on skin condition
-A Randomized, Open-Label, No Intake Controlled, Crossover Study-
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of SNR16 ingestion during the follicular phase on skin condition from multiple perspectives, using the non-ingested phase as a control. In addition, we will obtain basic information on skin condition and blood parameter variations between the follicular and luteal phases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perception of skin condition
Key secondary outcomes
Skin Moisture Content
Skin Moisture Evaporation
Skin smoothness
Skin roughness
Scaling
Wrinkles
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of SNR16
(1 pack per day for 6 days during follicular phase)
Interventions/Control_2
No intervention
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
[1] Those who experience changes in skin condition according to their menstrual cycle.
[2] Those with regular menstrual cycles (26-35 days).
[3] Those who are able to consume the test foods, participate in necessary examinations, and answer questionnaires according to the schedule instructed by the researcher.
Key exclusion criteria
[1] Those who may show severe allergic symptoms to foods (especially soybeans, gelatin, oranges).
[2] Habitual users of health foods or supplements containing vitamin D within 1 month of study entry.
[3] Those who have undergone cosmetic procedures (cosmetic surgery, collagen injection, laser, hair removal, etc.) within 6 months of the start of the examination.
[4] Those who are exposed to excessive ultraviolet rays, such as those who work outdoors for long hours on a daily basis.
[5] Those whose BMI deviates from 18.5 to 25.
[6] Pregnant or lactating mothers, or those who wish to become pregnant during the study period.
[7] Those who have some kind of chronic disease and are receiving drug treatment.
[8] Persons who are judged to be inappropriate as subjects by the principal investigator and the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakazima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings CO., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings CO., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
jimukyoku@tes-h.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 | 10 | Month | 24 | 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
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056038
