Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062781) titled 'Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment' on Sept. 2.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Rohto Pharmaceutical Co., Ltd.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to examine the safety, changes in skin condition, and impact on user experience associated with the use of face masks following Aesthetic Treatment
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Use a face mask once immediately after the treatment, and then use one once every night for two weeks starting from the day of the treatment.
Interventions/Control_2 - Apply Petrolatum once immediately after the treatment, and then use one once every night for two weeks starting from the day of the treatment.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Individuals aged 18 years or older at the time of obtaining consent
(2) Individuals undergoing the cosmetic procedure targeted by this study
(3) Individuals capable of completing documents such as consent forms and questionnaires
(4) Individuals who have received a full explanation regarding the study's purpose and content, possess the capacity to consent, have a clear understanding of the study, have voluntarily applied to participate, and have provided written consent to participate
Key exclusion criteria - (1) Individuals whom the principal investigator or study physician deems to have a significant difference in skin condition between the left and right sides of the face
(2) Individuals who have undergone cosmetic procedures, such as laser therapy, light therapy, or radiofrequency treatment, within one month prior to the start of the study
(3) Individuals planning to undergo facial cosmetic medical procedures other than the procedure targeted by this study during the study period
(4) Individuals with a history of allergies to cosmetics or to ingredients contained in the test product(including individuals who developed contact dermatitis caused by cosmetics within one year prior to the start of the study)
(5) Individuals likely to be exposed to excessive ultraviolet radiation during the study period
(6) Individuals who are pregnant or breastfeeding at the time of consent, or who wish to become pregnant during the study period
(7) Individuals who have participated in another human clinical trial within one month prior to the start of the study, or who plan to participate in one during the study period
(8) Individuals otherwise deemed unsuitable for participation in the study by the principal investigator or study physician
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 20 Day
Date of IRB - 2026 Year 08 Month 27 Day
Anticipated trial start date - 2026 Year 09 Month 03 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071871
Disclaimer: Curated by HT Syndication.