UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048899 |
|---|---|
| Receipt number | R000055308 |
| Scientific Title | A clinical study of anti-aging effect for test product |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2024/04/17 15:40:52 |
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Basic information
Public title
A clinical study of anti-aging effect for test product
Acronym
A clinical study of anti-aging effect for test product
Scientific Title
A clinical study of anti-aging effect for test product
Scientific Title:Acronym
A clinical study of anti-aging effect for test product
Region
| Asia(except Japan) |
Condition
Condition
Not applicable
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial is conducted for the effects of placental-extract cream on skin-aging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
kin anti-aging parameters, such as skin hydration, elasticity, lightness, dermal density, sagging, wrinkle and eyebag, are evaluated at baseline, 4 weeks and 8 weeks after treatment.
Key secondary outcomes
Assessment of self-questionnaires
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The participants apply the cream containing 1.5% porcine placental extract. The treatment is applied to the participants' whole face, except for the non-treated side of the crow's feet, twice a day in the morning and evening for 8 weeks.
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Korean female participants aged between 40 and 60 with wrinkle on their crow's feet and nasolabial fold; subjects who sign the informed consent of the study; and those who are cooperative and available for follow-up during the study period.
Key exclusion criteria
participants who are pregnant, in nursing condition, or planning to become pregnant; participants who are treated with immune-suppressant within one month from the conduct of the study; participants who participated in a previous study without an appropriate intervening period of one month between studies; participants who have sensitive or hypersensitive skin; participants who have damaged skin in or around the test site, which includes sunburn, tattoos, scars, or other disfiguration on the test site; participants who used similar treatment related to the study during the previous three months; participants who had an experience on test site (skin microdermabrasion, Botox and other skin treatment); participants who have chronic disease (diabetes, asthma, or high blood-pressure); participants who have atopic dermatitis; and participants who have any problem, which might interfere with the healing process.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Tsuji |
Organization
DHC Corporation
Division name
Primary Research Unit Primary Research Group 1
Zip code
261-0025
Address
Division 2, 2-42 Hamada, Mihama-ku, Chiba
TEL
043-275-4811
ktsuji@dhc.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Katayoshi |
Organization
DHC Corporation
Division name
Primary Research Unit Primary Research Group 1
Zip code
261-0025
Address
Division 2, 2-42 Hamada, Mihama-ku, Chiba
TEL
043-275-4811
Homepage URL
t-katayoshi@dhc.co.jp
Sponsor or person
Institute
DHC Corporation
Primary Research Unit Primary Research Group 1
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
Primary Research Unit Primary Research Group 1
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
DERMAPRO Ltd.
Address
DERMA B/D, 61, Seocho-daero, Seocho-gu, Seoul, Republic of Korea
Tel
+82(0)2-597-5435
dermapro@dermapro.co.kr
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
| 2022 | Year | 09 | Month | 09 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 12 | 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 | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055308
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