UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049200 |
|---|---|
| Receipt number | R000055865 |
| Scientific Title | Confirmation of improvement effects on skin function by inhalation of citrus oil-inducing odorant |
| Date of disclosure of the study information | 2023/10/13 |
| Last modified on | 2023/12/22 14:49:10 |
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Basic information
Public title
Confirmation of improvement effects on skin function by inhalation of citrus oil-inducing odorant
Acronym
Confirmation of improvement effects on skin function by inhalation of citrus oil-inducing odorant
Scientific Title
Confirmation of improvement effects on skin function by inhalation of citrus oil-inducing odorant
Scientific Title:Acronym
Confirmation of improvement effects on skin function by inhalation of citrus oil-inducing odorant
Region
| Japan |
Condition
Condition
Healthy female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether an inhalation of test odorant could reveal some kind of improvement effect on skin function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water-binding capacity, and skin viscoelasticity
Key secondary outcomes
1. VISIA TM Evolution (blotch, wrinkle, texture, pores, ultraviolet-blotch, brownish blotch, reddish blotch, porphyrin)
2. Blood-flow volume
3. Stress Check List 30
4. Multiple measurements of emotion using a multiple mood scale (40 questions)
5. Skin questionnaire
6. Pittsburgh Sleep Quality Index
7. Oguri-Shirakawa-Azumi sleep inventory ver. MA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Inhalation of a test odorant-containing tap-water mist (100 mL), which is emitted from an aroma-diffuser, to the subject at her normal bedtime for four weeks.
Interventions/Control_2
Inhalation of a deionized water-containing tap-water mist (100 mL), which is emitted from an aroma-diffuser, to the subject at her normal bedtime for four 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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy female subjects ranging in age from 30 to 44, at informed consent.
(2) Subjects who feel pretty stress, skin dryness, and skin tension.
(3) Subjects not being poor at a sweet-smelling citrus (kabosu).
(4) Subjects equipped with a capacity to breath in the odorant from the diffuser, being at home.
(5) Subjects who can give informed consent to partake in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional/supplementary (e.g., gamma-aminobutyric acid, glucosylceramide, sodium hyaluronate, L-theanine)/health foods, which might affect the test results.
(2) Subjects who have taken affecting medicines (e.g., skin roughness-improving drug, and sleeping pill), and have any difficulty in refraining from taking them during this trial.
(3) Subjects with the condition of being over-sensitiveness to cold, even during the summer season.
(4) Subjects who realized that the subjects themselves must be in a state of menopausal symptom.
(5) Subjects with nasal congestion and/or wrong judgement of fragrance.
(6) Subjects falling into the habit of smoking within one year before this trial.
(7) Subjects having a bruise and/or a hurt near the skin-measuring position (left cheek part).
(8) Subjects having their skin roughness due to pollinosis, during this trial.
(9) Subjects with excessive suntan, and/or some kind of work/sport outside for a long time.
(10) Subjects who are possible to go on a trip, and/or a business one during this trial, which might affect the test-device usage.
(11) Subjects who are now under a specific facial care (e.g., facial/body treatment, electric facial, peeling, laser therapy, and hair removal) at an outside agency.
(12) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(13) Pregnant, lactating women, or possibly pregnant ones.
(14) Subjects suffering from atopic/contact dermatitis, and skin hypersensitivity.
(15) Subjects who are now under other clinical tests with some kind of medicine and/or health food, or partook in those within four weeks before this trial, or are planning to participate in those after giving informed consent to take part in this trial.
(16) Others who have been determined as ineligible for participation, judging from the investigator's opinions.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Uesugi |
Organization
Ogawa & Co., Ltd.
Division name
Operating Officer
Zip code
103-0023
Address
4-1-11 Nihonbashi-Hon-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-3270-1720
uesugi.takashi@ogawa.net
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Ogawa & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Integrative and Global Majors, Tsukuba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 13 | 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 | 21 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 09 | 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 | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055865
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