Performance examination test of the skin moisture meter for healthy adults, patients with asteatosis Part 2

JRCT ID: jRCTs032240038

Registered date:17/04/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Asteatosis
• Date of first enrollment: 26/04/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): The water content of the skin at the measurement sites of the research subject will be measured using the test and reference devices on the measurement date.

Outcome(s)

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

Secondary Outcome

<Other Outcomes>
- Relationship between Overall Dry Skin score (ODS) on the extensor forearm and lower back and the water content of the skin
- Relationship between Overall Dry Skin score (ODS) at each measurement site and the water content of the skin measured by test device (by sex)
- Relationship between Overall Dry Skin score (ODS) at each measurement site and the water content of the skin measured by reference device
- Relationship between Overall Dry Skin score (ODS) at each measurement part and the water content of the skin measured by reference device (by sex)
-Relationship between the water content of the skin by test device and that by reference device at each measurement site

<Safety Outcome>
- Adverse event

Key inclusion & exclusion criteria

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

Include criteria

Persons meeting all of the following criteria.
Healthy adults: (1)(2)(4)
Asteatosis patients: (1)(3)
(1) Healthy adults: 18 years old and over and under 60 years old (at the time of signed consent) Asteatosis patients: 18 years and older (at the time of signed consent)
(2) No clinical findings of dryness in any part of the body and no history of diagnosis or treatment of dryness.
(Excluded are those who, even if not diagnosed by a physician, have felt dryness in the site to be measured and have used topical agents (including OTC drugs, quasi-drugs, and cosmetics) within 6 months.)
(3) Patients who have asteatosis caused by physiological factors, are diagnosed with dry findings with Overall Dry Skin score (ODS) of 1 to 3 on lower leg (outer central site)
Patients with dryness sign on either side of the lower leg may be included in the study. Patients without dry signs on the forearm or lower back may also be included in the study.
(4) Body Mass Index(BMI):18.5 or more and less than 25.0

Exclude criteria

(1) Person with a history or complications of serious allergy (shock, anaphylaxis-like symptoms or signs).
(2) Person with any of the following diseases.
1) Malignancies, except for patients whose malignancies are not being treated and does not recur or for 5 years or more, those have history of radical treatment of cervical intraepithelial carcinoma at the time of signed consent.
2) Diabetes mellitus
3) Chronic renal failure
4) Hyperhidrosis or other diseases with abnormal sweating
(3) Person with serious diseases of the heart, liver, kidneys, lungs, and blood that investigators have considered are inappropriate for participate in study.
(4) (Healthy adults only) The research subject or any parent, sibling, or child related by blood to the research subject has a following history or complication.
-Asteatosis which developed by age 60
- Bronchial asthma
- Atopic dermatitis
(5) (Healthy adults only) Persons who are showing allergic symptoms. Those who are showing allergic rhinitis including hay fever or allergic conjunctivitis will not be included in this study.
(6) (Healthy adults only) Persons with a history of drug or food allergies.
(7) Persons who are allergic to alcohol.
(8) Person with abnormal findings (eczema, dermatitis, scratch trace, wound, scar, excessive sunburn, tattoo, and the like) on any of the sites to be measured. However, symptoms of the primary disease in patients with asteatosis, are excluded.
(9) Person with history or complications of drug dependence or the alcohol dependence.
(10) Person in whom a measurement site is hairy.
(11) Person who have received permanent hair removal performed on the site to be measured. Or those who regularly undergo cosmetic hair removal procedures. (If more than six months have passed since the last treatment, the patient may be included in this study).
(12) Patients with asteatosis caused by systemic diseases or medical practice such as administration of anticancer drugs or radiotherapy.
(13) Person who used topical agents (including over-the counter drugs, quasi-drugs, and cosmetics) on any of the sites to be measured within two days before the measurement date.*
(14) Person who took oral corticosteroids within 3 months (90 days) before the measurement date.*
(15) Person who subject to phototherapy for any of the sites to be measured within three months (90 days) before measurement date.*
(16) Person using the molecularly target therapy(biologics, JAK inhibitor, and the like) within six months (180 days) before measuring date.*
(17) Person enrolled in this study in the past.
(18) Persons who have not yet passed 120 days from the date of participation in another clinical research###, clinical trial or post-marketing clinical study (date of last administration of the investigational drug or study drug) to the date of measurement at this study, or who are currently participating in another clinical research###, clinical trial or post-marketing clinical study.
###: Excluding studies that the investigators determines will not affect the conduct of this study.
(19) Pregnant women and those who may be pregnant.
(20) Person who is judged by the principal investigators to be ineligible for this study for any other reason.
*: To be checked only at the time of qualification on the measurement date

Related Information

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