Unique ID issued by UMIN | UMIN000052729 |
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Receipt number | R000060162 |
Scientific Title | Safety evaluation for quasi-drug use at the Pico Laser Toning irradiation site for the facial melasma |
Date of disclosure of the study information | 2023/11/09 |
Last modified on | 2023/11/08 15:57:13 |
Safety evaluation for quasi-drug use at the Pico Laser Toning irradiation site for the facial melasma
Safety evaluation for quasi-drug use at the Pico Laser Toning irradiation site for the facial melasma
Safety evaluation for quasi-drug use at the Pico Laser Toning irradiation site for the facial melasma
Safety evaluation for quasi-drug use at the Pico Laser Toning irradiation site for the facial melasma
Japan |
Melasma
Dermatology | Adult |
Others
NO
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 Pico Laser Toning irradiation for the facial melasma.
Safety
Exploratory
Pragmatic
Not applicable
Safety evaluation for quasi-drug use after Pico Laser Toning irradiation:
The difference in the adverse events in group comparison between the quasi-drug use and non-treated.
Efficacy evaluation for quasi-drug use after Pico Laser Toning irradiation for improvement of melasma.
Regarding the following 6 parameters, the changes from the initial value will be evaluated. And, a group comparison between the quasi-drug use and non-treated will be conducted.
1. Assessment of MASI score by dermatologist
A dermatologist will evaluate the MASI score of facial melasma.
2. Assessment of IGA grade by dermatologist
A dermatologist will evaluate the IGA grade of facial melasma.
3. Self-assessment by participants
Participants themselves will evaluate the IGA grade of facial melasma.
4. Facial imaging analyses:
Facial imaging analysis will be performed by VISIA and calculated the pigmentation and redness score with the attached software.
Additional evaluation
5. Evaluation of facial measurement parameters
Skin water contents, Trans epidermal water loss, and Viscoelasticity, sebum secretions will be measured.
6. Self-assessment of skin sensation by participants
Participants themselves will evaluate the skin sensation by questionnaires.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Device,equipment | Other |
Pico Laser Toning and quasi-drug treatment group
Pico Laser Toning treatment group
40 | years-old | <= |
59 | years-old | >= |
Female
(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 melasma
(3) Healthy Japanese female ages 40 to 59 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 bring their own cosmetics of facial wash and makeup on the day of the measurement.
(1) Persons who have skin symptoms such as external wound, acne, and eczema, etc. on the face
(2) Persons who have a history of surgery or injections on the face
(3) Persons who have undergone cosmetic surgery in the past and are currently in the downtime
(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, photo-facial, injection therapy, HIFU, incision, thread lift, etc.) that affect the shape and/or skin 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 with a history of cancer of the head and/or neck
(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) Persons who have experienced rashes from plants, trees, or hair dye
(20) Other persons deemed inappropriate by the research physician
48
1st name | Kenshi |
Middle name | |
Last name | Yamasaki |
ALOOP CLINIC & LAB
Aesthetic Dermatology
1040061
Pola Ginza Building, 1-7-7 Ginza, Chuo-ku, Tokyo
08010048080
Yamasaki.ginza@gmail.com
1st name | Fumiya |
Middle name | |
Last name | Yamaji |
POLA Chemical Industries, Inc.
Frontier Research Center
2440812
560 Kashio-cho, Totsuka-ku, Yokohama
0458267232
f-yamaji@pola.co.jp
POLA Chemical Industries, Inc.
POLA Chemical Industries, Inc.
Profit organization
Japan
ALOOP CLINIC & LAB
The Ethics Committee of Healthcare Systems Co., Ltd.
1-14-18, Shirokane, Showa-ku, Nagoya-shi, Aichi
052-734-8885
soumu@hc-sys.jp
NO
2023 | Year | 11 | Month | 09 | Day |
Unpublished
48
No longer recruiting
2023 | Year | 09 | Month | 07 | Day |
2023 | Year | 09 | Month | 08 | Day |
2023 | Year | 09 | Month | 16 | Day |
2024 | Year | 08 | Month | 31 | Day |
2023 | Year | 11 | Month | 08 | Day |
2023 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060162
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