UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050470 |
|---|---|
| Receipt number | R000057415 |
| Scientific Title | 4-week continuous skin environmental improvement test of Blue rose extract powder capsule and placebo products |
| Date of disclosure of the study information | 2023/03/02 |
| Last modified on | 2023/05/29 09:58:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
4-week continuous skin environmental improvement test of Blue rose extract powder capsule and placebo products
Acronym
4-week continuous skin environmental improvement test of Blue rose extract powder capsule and placebo products
Scientific Title
4-week continuous skin environmental improvement test of Blue rose extract powder capsule and placebo products
Scientific Title:Acronym
4-week continuous skin environmental improvement test of Blue rose extract powder capsule and placebo products
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the effects of blue rose extract on skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin hydration in stratum corneum and trans epidermal water loss.
Key secondary outcomes
Sebum level
Skin flexibility (R0)
Skin resilience (R7)
pH
Melanin level
Hemoglobin level
Multiple peeling
Melanin index measured with a color-difference meter
Hemoglobin index measured with a color-difference meter
Hemoglobin oxygen saturation (HbSO2) measured using a color-difference meter
Brightness of skin (L*) measured using a color-difference meter
Redness of skin (a*) measured using a color-difference meter
Yellowness of skin (b*) measured using a color-difference meter
Wrinkles analyzed using a replica image
Skin pores analyzed using a replica image
Skin texture analyzed using a replica image
Spots analyzed using a VISIA
UV-induced spots analyzed using a VISIA
Brown spots analyzed using a VISIA
Wrinkles analyzed using a VISIA
Skin texture analyzed using a VISIA
Skin pores analyzed using a VISIA
Erythema analyzed using a VISIA
Porphyrin spots analyzed using a VISIA
Body surface temperature
Visually assessed dullness
Visually assessed spots
Visually assessed reddish blur
Visually assessed acnes
Visually assessed skin pore openings
Visually assessed skin pore darkness
Visually assessed skin texture mesh roughness
Visually assessed wrinkles
Visually assessed rough skin
Visually assessed resilient skin appearance
Visually assessed transparency
Questionnaire
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
Test product was taken once a day for 4 weeks at the prescribed dose (1 capsule) at bedtime.
Interventions/Control_2
Placebo product was taken once a day for 4 weeks at the prescribed dose (1 capsule) at bedtime.
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
| 40 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese healthy female subjects, between 40 years and 50 years old (inclusive) at the time of consent.
2. Subjects whose skin characteristics fall under the skin type III or IV (according to the Fitzpatrick classification).
3. Those who are aware of dry skin.
Key exclusion criteria
1. Subjects with a skin disease such as psoriasis.
2. Subjects with a skin disease such as atopic dermatitis.
3. Subjects taking medications or applying medicines topically that are likely to affect the test results.
4. Subjects with contact allergy or who might exhibit an allergic symptom.
5. Subjects who are undergoing dermatological treatment.
6. Subjects with eczema, rash, sunburn, fleck, or scratch marks on the site of the skin test.
7. Subjects who are pregnant or likely to be, or those who are breast feeding.
8. Subjects who participate in, at the time of initiation of this study, another test that interferes with this study or subjects who are scheduled to attend, during the tests, another test that interferes with this study.
9. Subjects who have tattoos, tattoo stickers, body paints, etc. on the site of the skin test.
10. Subjects who received chemical peel, laser treatment, light irradiation treatment, skin treatment such as injection, or surgery, or beauty therapy on the site of the skin test within 4 weeks by the start of the test.
11. Subjects who are judged as unsuitable by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoyagi |
Organization
KINJIRUSHI Co., Ltd
Division name
R&D Division
Zip code
454-8526
Address
2-6-1 Yahata-Hontori, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-361-3859
daisuke-aoyagi@kinjirushi.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoyagi |
Organization
KINJIRUSHI Co., Ltd
Division name
R&D Division
Zip code
454-8526
Address
2-6-1 Yahata-Hontori, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-361-3859
Homepage URL
daisuke-aoyagi@kinjirushi.co.jp
Sponsor or person
Institute
KINJIRUSHI Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
KINJIRUSHI Co., Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kirei Testing Labo Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trial ethics committee
Address
3F Haseman Bldg., 2-11-6 Tomioka, Koto-ku, Tokyo , Japan
Tel
03-5646-2434
m-yabuki@saticine-md.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
株式会社きれいテストラボ
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 02 | 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
47
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 | 02 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057415
