Performance examination test of the horny layer moisture meter for healthy adults, patients with asteatosis and patients with atopic dermatitis
- Conditions
- Asteatosis,Atopic dermatitis
- Registration Number
- JPRN-jRCTs032220396
- Lead Sponsor
- Tsunemi Yuichiro
- Brief Summary
o consistent trend was obtained for the variation of mean water content of the stratum corneum with increasing ODS for each study group by site and by ODS. Comparison of stratum corneum water content by site and pruritus NRS in each study group showed no clear correlation between water content of the stratum corneum and pruritus NRS. There were no adverse events or medical device adverse event that occurred in this study, and the safety of the stratum corneum moisture analyzer was considered safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
The person who fulfills either criteria of (2) (3) (4) in addition to following (1)
(1)Person 18 years and older at the time of informed consent
(2)Person without systemic nowhere dry findings
(3)Patients who have asteatosis caused by physiological factors, with dry findings that ODS is 1 to 3 on lower leg (anterior surface)
(4)Patients who have atopic dermatitis, with dry findings that ODS is 1 to 4 on lower leg (anterior surface)
(1)Person with a history or complications of serious allergy (shock, anaphylaxis-like symptoms)
(2)Person with any of the following diseases
1)Serious diseases of the heart, liver, kidneys, lungs, and blood that investigator have considered are inappropriate for participate in study.
2)Malignant tumor, except for there is no treatment and no recurrence for the past 5 years or history of curative treatment for the cervical intraepithelial neoplasia at the time of informed consent
3) Skin diseases other than the asteatosis or atopic dermatitis that occur at the evaluation area of this study
(3)Person with abnormal findings (eczema, dermatitis, scratch trace, wound, scar, excessive sunburn, tattoo, and the like) in one of the either the left or right forearm, the left or right lower leg, or the trunk (lower left or right back)
However, symptoms of the primary disease in patients with asteatosis or atopic dermatitis, respectively, are excluded.
(4)Person with history or complications of drug dependence or the alcohol dependence
(5)Person that a measurement position is hairy
(6)Person with asteatosis due to systemic disease or medical act such as the administration of anticancer drug and the radiotherapy
(7) Person used topical drugs (including over-the-counter drugs, quasi-drugs, and cosmetics) for either the left or right forearm, the left or right lower leg, or the trunk (lower left or right back) within seven days before measurement date
(8) Person who took oral antihistamine or oral antiallergic drug within 14 days before measuring date
(9) Person who took oral corticosteroids within 3 months (90 days) before the start of treatment
(10)Person who subjetct to phototherapy for one of the either the left or right forearm, the left or right lower leg, or the trunk (lower left or right back) within three months (90 days) before measuring date
(11) Person using the target medicine (biological preparation, JAK inhibitor, and the like) molecular within six months (180 days) before measuring date
(12) Person enrolled in this study in the past
(13) Person participating in other clinical studies(excluding studies that are not considered to affect the implementation of this study), clinical trials or post-marketing clinical trials
(14) COVID-19 patients (including asymptomatic pathogen carriers) or who suspected COVID-19 infection
(15) Person who were found to have close contact with COVID-19 patients (including asymptomatic pathogen carriers) within 14 days prior to the start of treatment
(16) Person who is judged by the principal investigator or sub- investigator to be ineligible for this study for any other reason
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method