UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054557 |
|---|---|
| Receipt number | R000062342 |
| Scientific Title | Safety evaluation of formulation use containing active ingredient of quasi-drug at microneedle radiofrequency treatment site for the treatment of enlarged facial pores |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2025/08/05 16:29:47 |
* 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
Safety evaluation of cosmetic use at aesthetic medical treatment site for the enlarged facial pores
Acronym
Safety evaluation of cosmetic use at aesthetic medical treatment site for the enlarged facial pores
Scientific Title
Safety evaluation of formulation use containing active ingredient of quasi-drug at microneedle radiofrequency treatment site for the treatment of enlarged facial pores
Scientific Title:Acronym
Safety evaluation of formulation use containing active ingredient of quasi-drug at microneedle radiofrequency treatment site for the treatment of enlarged facial pores
Region
| Japan |
Condition
Condition
Enlarged facial pore
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As aesthetic medicine becomes more popular, the number of cases in which quasi-drug use after mechanical treatments is increasing. Therefore, we will evaluate whether formulation use containing active ingredient of quasi-drug can be safe and effective after microneedle radiofrequency treatment for the enlarged facial pore.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety evaluation for formulation containing active ingredient of quasi-drug after microneedle radiofrequency treatment for enlarged pores:
Compare the adverse events in the group using formulation containing active ingredient of quasi-drug with those in the group using placebo.
Key secondary outcomes
Efficacy evaluation of formulation containing quasi-drug active ingredient for improvement of enlarged facial pores.
For the following parameters, the initial values will be compared to the values after treatment of the group using formulation containing active ingredient and the group using placebo. In addition, comparisons between values of these two groups will be made.
1. Visual evaluation by dermatologist
2. Photographic evaluation by dermatologist
3. Subject questionnaires
4. Instrument evaluation (Corneometer, Tewameter, Cutometer, and Sebumeter)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Microneedle radiofrequency and formulation containing active ingredient of quasi-drug treatment group
Interventions/Control_2
Microneedle radiofrequency and placebo treatment group
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
| 49 | years-old | > |
Gender
Female
Key inclusion criteria
1.Persons who have received an explanation of this research, understand the purpose of the research and the risks involved, and agree to participate in the research of their own free will (i.e., persons who have given their informed consent)
2.Healthy Japanese female between the ages of 30 to 49 with enlarged facial pores on their cheeks.
3.Persons who can fill out the consent form and other documents.
4.Persons who can come to the designated facility on the day of the measurement.
5.Persons who can be administered local anesthesia (e.g., lidocaine)
6.Persons who can bring their own cosmetics of facial wash and makeup on the day of the measurement.
7.Persons who can consent to the use of their portraits in media such as product brochures, scientific articles, and distribution of research results in the Web.
Key exclusion criteria
1.Persons who have experienced adverse events such as rash, redness, etc. caused by the ingredients of the test preparation.
2.Persons who have skin conditions such as trauma, acne, eczema, etc. on the cheeks that may affect the examination.
3.Persons who have difficulty enduring the pain caused by needles due to reasons such as difficulty with local anesthesia, or those with aichmophobia.
4.Persons who have a history of surgery or injections (filler, metal, etc.) in the cheeks or those who have received injections such as Botox in the cheeks.
5.Persons who have undergone aesthetic surgery in the past and are currently in the downtime period.
6.Persons who have experienced severe pain, erythema, or scarring as a result of aesthetic surgery.
7.Persons with atopic dermatitis.
8.Persons with allergies to disinfectant alcohol, rubber, metal, or leather products.
9.Persons who taking medicine that may affect the aesthetic surgery treatment (antiplatelet drugs (aspirin, etc.), anticoagulants, etc.), persons who have hemostatic dysfunction, or those who are prone to internal bleeding.
10.Persons who are pregnant, lactating, or planning to become pregnant during the study period.
11.Persons who drink alcohol excessively on a regular basis
12.Persons who are likely to be exposed to significant sunlight exposure or persons who have been or will be attending tanning salons during the period of participation.
13.Persons with a history of liver damage, kidney disease, heart disease, anemia (*persons who have been to the hospital multiple times in the past due to anemia), epilepsy or using a pacemaker, diabetes, or receiving hormone replacement therapy.
14.Persons who are currently participating in another clinical study or will participate in another clinical study during the study period.
15.Persons with fever (*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk)
16.Other persons deemed inappropriate by the research physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yamasaki |
Organization
ALOOP CLINIC&LAB
Division name
Aesthetic Dermatology
Zip code
104-0061
Address
4th Floor, Pola Ginza Building, 1-7-7 Ginza, chuo-ku, Tokyo
TEL
0120-506-182
k-yamasaki@aloop.clinic
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Okada |
Organization
POLA Chemical Industries,Inc.
Division name
Frontier Research Center
Zip code
2440812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
045-826-7232
Homepage URL
keitaro-okada@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
ALOOP CLINIC&LAB
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
ALOOP CLINIC & LAB
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 07 | 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
30
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
| 2024 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062342
