Performance examination test of the horny layer moisture meter for healthy adults, patients with asteatosis and patients with atopic dermatitis

JRCT ID: jRCTs032220396

Registered date:19/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Asteatosis,Atopic dermatitis
• Date of first enrollment: 10/11/2022
• Target sample size: 240
• Study type: Other

Outcome(s)

• Primary Outcome: Relationship between Overall Dry Skin score (ODS) and water content of stratum corneum

Secondary Outcome

-Relationship between water content of stratum corneum, and pruritus NRS
-Relationship between Overall Dry Skin score (ODS) and pruritus NRS
-Relationship between water content of stratum corneum and evaluates severity of atopic dermatitis
-Examination of boundary zone of skin dryness
-Relationship between the presence of erythema and water content of stratum corneum at the part rated ODS3 in patients with asteatosis.
-Investigation of method for adopting measurement results of water content of stratum corneum
-Investigation of differences between measurers in measurement results of water content of stratum corneum

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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)

Exclude criteria

(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

Related Information

• Primary Sponsor: Tsunemi Yuichiro
• Secondary Sponsor: Maruho Co.,Ltd.