UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052731 |
|---|---|
| Receipt number | R000060165 |
| Scientific Title | Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging |
| Date of disclosure of the study information | 2023/11/09 |
| Last modified on | 2024/06/03 17:29:15 |
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Basic information
Public title
Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging
Acronym
Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging
Scientific Title
Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging
Scientific Title:Acronym
Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging
Region
| Japan |
Condition
Condition
Sagging
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 quasi-drugs can be safely used after HIFU treatment for the facial sagging
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety evaluation for quasi-drugs use after HIFU:
Difference in adverse events associated with the use of quasi-drugs in comparison between groups using quasi-drugs and groups using placebo
Key secondary outcomes
Efficacy evaluation for quasi-drug use after HIFU treatment for improvement of sagging
Regarding the following 4 parameters, the changes from the initial value will be evaluated. And, a group comparison between the quasi-drug use and placebo use will be conducted.
1. Assessment of IGA grade by dermatologist
A dermatologist will evaluate the IGA grade of sagging.
2. Self-assessment by participants
Participants themselves will evaluate the IGA grade of sagging.
3. Facial imaging analyses:
Facial imaging analysis will be performed by VISIA and/or Vectra3D and calculate the sagging level.-
4. Self-assessment of skin sensation by participants
Participants themselves will evaluate the skin sensation by questionnaires.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
HIFU and quasi-drug treatment group
Interventions/Control_2
HIFU 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
| 40 | years-old | <= |
Age-upper limit
| 54 | 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) Persons with facial sagging
(3) Healthy Japanese female ages 40 to 54 years old who do not meet the exclusion criteria
(4) Persons who can fill out the consent form and other documents
(5) Persons who can come to the designated facility on the day of the measurement
(6) Persons who can answer the questionnaire about BMI and whose current BMI is between 18.5 and 25.
(7) Persons who can bring their own cosmetics of facial wash and makeup on the day of the measurement.
Key exclusion criteria
(1) Persons who have skin symptoms such as external wound, acne, eczema, etc. on the face (from the eyebrows to the chin)
(2) Persons who have a history of surgery or injections (filler or metal) on the face (from eyebrows to chin tip)
(3) Persons who have undergone cosmetic surgery in the past and are currently in the downtime period
(4) Persons who have experienced severe pain, erythema, or scarring after undergoing cosmetic surgery in the past
(5) Persons who have undergone cosmetic medical surgery (laser irradiation, photofacial, injection therapy, HIFU, incision, thread lift, etc.) that affect the shape and/or color tone of the face
(6) Persons with a history of atopic dermatitis
(7) Persons with allergies to disinfectant alcohol and/or rubber
(8) Persons who are taking medicines (anticoagulants, etc.) that may affect the HIFU treatment
(9) Persons who are pregnant, lactating, or planning to become pregnant during the study period
(10) Persons who drink alcohol excessively on a regular basis
(11) Persons who regularly go or plan to go to tanning salons or plan to do so during the study period
(12) Persons who are expected to suffer from severe hay fever* during the study period (*level requiring a hospital visit)
(13) Persons who are likely to be exposed to significant sunlight during the study period (e.g., Daily exercise during the daytime)
(14) Persons with a history of serious hepatic disorder, renal disorder, or myocardial infarction
(15) Persons with severe anemia (* Persons who have been to the hospital multiple times in the past due to anemia)
(16) Persons receiving hormone replacement therapy
(17) Persons who are currently participating in another clinical study or will participate in another clinical study during the study period
(18) Persons with fever (*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk)
(19) Other persons deemed inappropriate by the research physician
Target sample size
24
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
1040061
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 | Fumiya |
| Middle name | |
| Last name | Yamaji |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
2440812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
0458267232
Homepage URL
f-yamaji@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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirokane, Showa-ku, Nagoya-shi, Aichi
Tel
052-734-8885
soumu@hc-sys.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 | 11 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.pola-rm.co.jp/pdf/release_20240515_1.pdf
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Primary outcome: A dermatologist confirmed skin observations and adverse events, which were attributed to winter dryness and common HIFU procedures. These events were not related to quasi-drugs, and the study was deemed mostly safe.
Secondary outcome: IGA improved in both groups, with greater improvement in the quasi-drug group compared to the placebo group. Image analysis showed improvements in 3D cheek shape and skin viscoelasticity in both groups, with higher improvements in the quasi-drug group.
Results date posted
| 2024 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As per the recruitment criteria
Participant flow
After coming to the clinic, wash and acclimatize your face, and be examined by a dermatologist. After that, a face photo will be taken and equipment measurement will be carried out. Then, HIFU treatment (when only at first visiting) was performed. Again, a doctor's examination is conducted. Finally, fill out the questionnaire.
After coming back home, the test product will be used until the next visit.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2023 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060165
