UMIN-ICDS Clinical Trial

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

Sagging

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Pola Ginza Building, 1-7-7 Ginza, Chuo-ku, Tokyo

TEL

08010048080

Email

Yamasaki.ginza@gmail.com

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

Email

f-yamaji@pola.co.jp

Institute

POLA Chemical Industries,Inc.

Institute

Department

Personal name

Organization

POLA Chemical Industries,Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of Healthcare Systems Co., Ltd.

Address

1-14-18, Shirokane, Showa-ku, Nagoya-shi, Aichi

Tel

052-734-8885

Email

soumu@hc-sys.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

24

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

Recruitment status

No longer recruiting

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 related information

Registered date

2023

Year

11

Month

08

Day

Last modified on

2023

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060165