Patients who had skin problems caused by masks
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Study 1: Those that wear masks on a daily basis. Gender-neutral. Study 2: Subjects are employees of TOKIWA Pharmaceutical Co., Ltd. who wish to participate in the study. Study 3: Subjects who visited Takano Medical Clinic due to skin problems caused by a mask, who were judged by the investigator to be useful for mask guidance and skin care guidance based on their skin findings and interviews, and who wished to participate in the study.
Exclusion criteria
Exclusion criteria: Study 1:None in particular. Study 2:In the presence of serious skin disease Study 3:If you have serious skin disease.As a rule, those who cannot be seen at the end of the study (4 weeks later).In addition, the investigator judges it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (7)Endpoint (study 3 endpoint) a) Safety end point The duration of use of the test article in all subjects is the same 4 weeks, and changes in skin symptoms are observed at the start of the test and at the end of the test (after 4 weeks). However, when an adverse event occurs and the drug is discontinued during the study period, the skin condition should be monitored at the end of the study. At the end of the study (4 weeks later), the investigator will determine the safety of the test article based on the occurrence of adverse reactions in the following 4 steps. [Safety] Can be used without adverse reactions, etc. [Questionable safety]. Drug-related adverse events are unclear. [Not safe]. The use could not be continued due to side effects. [Unable to determine] The results of this test cannot be determined alone. The objective of this study is to: (1) target a safety endpoint of at least 90% safety assessment. b) Efficacy end point The analysis of physiological skin active substances related to the water content of the stratum corneum, transepidermal water transpiration, sebum, inflammation in the stratum corneum, keratinization and skin barrier function before and after the test is carried out. | — |
Countries
Japan
Contacts
TOKIWA Pharmaceutical Co., Ltd. NOV Academic Research