UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052115 |
|---|---|
| Receipt number | R000059480 |
| Scientific Title | An efficay test for the cosmetic product containing stable neutral vitamin C derivative for 24 weeks on people with senile pigment spots. |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2024/05/24 13:51:56 |
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Basic information
Public title
An efficay test for the cosmetic product containing stable neutral vitaminC derivative for 24 weeks on people with senile pigment spots.
Acronym
An efficay test for the cosmetic product containing stable neutral vitaminC derivative for 24 weeks on people with senile pigment spots.
Scientific Title
An efficay test for the cosmetic product containing stable neutral vitamin C derivative for 24 weeks on people with senile pigment spots.
Scientific Title:Acronym
An efficay test for the cosmetic product containing stable neutral vitamin C derivative for 24 weeks on people with senile pigment spots.
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the improvement of lentigo senilis by continuous apply of stable neutral vitaminC derivative for 24 weeks in Japanese women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observing changes in stains
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Examined sample: Apply cosmetics containing stable neutral vitaminC derivative for 24 weeks
Interventions/Control_2
Apply placebo cosmetic product for 24 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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1.Those who indicate their intention to participate in the study, understand the explanation, and can obtain written consent to participate in the study.
2.Healthy Japanese women between the ages of 20 and 55 who do not meet the exclusion criteria.
3.Persons who can write on documents such as consent forms, questionnaire forms, diaries, etc.
4.Those who can come to the designated facility on the measurement date.
5.Persons with lentigo senilis on the left and right sides of the face.(The stain level is about 1 to 3.)
6.Those who are conscious of dry skin.
7.Those who do not currently use products intended for whitening effect. Subjects who have never had rough skin when using products with a whitening effect in the past.
8.People whose daily care after washing their face is limited to using lotion or emulsion.
Key exclusion criteria
1.People with severe hay fever.
2.Those who are being treated for chronic skin diseases such as atopic dermatitis.
3.Subjects who are likely to expose the test site to sunlight during the test period.(Daily outdoor sports, etc.)
4.Those who have taken medicines containing tranexamic acid, vitamin C, or L-cysteine for skin whitening within 2 months before the start of the study.
5.Persons who have had allergic symptoms to cosmetics, etc. in the past.
6.People who regularly drink large amounts of alcohol.
7.Those who have a history of serious gastrointestinal disorder, liver disorder, renal disorder, myocardial infarction, mental illness, etc.
8.Persons with severe anemia.
9.Those who are currently pregnant, breastfeeding, or wish to become pregnant during the study period.
10.Those who have a family member working for a pharmaceutical manufacturer or cosmetics company.
11.Those who are currently participating in clinical trials, usage surveys, and product monitors for cosmetic products, pharmaceuticals, etc., or those who have participated within the last three months.
12.Subjects who are otherwise ineligible for participation in this study by the investigater.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc.
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
sakurai@inforward.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc.
Division name
EBISU skin research center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
Inforward, inc.
Institute
Department
Personal name
Funding Source
Organization
Dr's Choice 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
General Incorporated Association Clinical Research Review Center
Address
2972-8-603, Ishikawamachi, Hachioji-chi, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 09 | 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
28
Results
The level of stains in the areas where the test product was used was significantly reduced . The L* value in and near the stain area increased significantly, and the melanin value decreased significantly. In addition, 24 weeks after the start date, scores for scale and irritation decreased in the areas where the test product was used, and a significant difference was observed, and the b* value of the blemish area and the melanin value of the blemish area and the area near the blemish decreased.
Results date posted
| 2024 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, the subjects were healthy Japanese women between the ages of 20 and 55 who had senile pigment spots on the left and right sides of their faces and were aware of dry skin. We conducted a double-blind, placebo-controlled, randomized controlled trial of 28% combination product MIRAVC, a stable neutral vitamin C derivative, for 24 weeks to select 28 patients and investigate the improvement of senile pigment spots. Ta. During the study period, 1 patient requested discontinuation due to the onset of an adverse event, and the study was completed in 27 patients.
In addition to the basic cosmetics they usually use, subjects were given pre-assigned test products (products containing 28% stable neutral vitamin C derivative MIRAVC) and control products (products containing no stable neutral vitamin C derivatives MIRAVC 28%). The subjects used the product on the left and right sides of their faces for 24 weeks at home, and visited the test site before use, 12 weeks after use, and 24 weeks after use. On the observation day, participants underwent skin observation, skin measurements, and photography by a dermatologist, and completed a questionnaire.
Participant flow
Adverse events
In this study, one adverse event (ID021) occurred. ID021 experienced itching, redness, and a feeling of heat on his left and right cheeks and forehead when he woke up 3 days after using the test product, so he stopped using the test product. No treatment was given, and on the 3rd day of discontinuing use, the symptoms abated (improved) and the subjective symptoms disappeared. Yes, the possibility of irritant contact dermatitis cannot be ruled out, but allergic contact dermatitis was ruled out, and the investigator judged that the test product could be reused. However, the study was discontinued due to the patient's request to refuse reuse.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 23 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059480
