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

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

240

The background of the study subjects in this study (healthy adults, patients with asteatosis and atopic dermatitis, in that order) is given below. The median (min-max) age at the time of obtaining consent in the efficacy analysis population was 34.5 (20-57), 50.0 (19-73), and 33.0 (18-63) years. Percentage of gender was 32.5%, 43.3%, and 47.5% for males, and 67.5%, 56.7%, and 52.5% for females, respectively. The percentages of patients with a history of treatment for the primary disease were 0.0%, 52.5%, and 78.8%, respectively, and the percentages of patients with a medical history were 10.0%, 18.3%, and 12.5%, respectively. Complications were "none" in all groups. The percentages of presence of lesion at each location (patients with asteatosis and atopic dermatitis, in the same order) were 54.2% and 48.8% for the left forearm (flexion side), 54.2% and 51.2% for the right forearm (flexion side), 86.7% and 76.2% for the left forearm (extension side), 87.5% and 82.5% for the right forearm (extension side), and 100.0% for the left lower leg ( left lower leg (front): 100.0% and 98.8%, right lower leg (front): 99.2% and 98.8%, left lower leg (rear): 88.3% and 87.5%, right lower leg (rear): 90.0% and 88.8%, trunk (left lower back): 58.3% and 67.5%, trunk (right lower back): 57.5% and 67.5%, other were 58.3% and 67.5%, 57.5% and 67.5% for the trunk (lower right back), and 3.3% and 13.8% for other parts of the body. The age at the time of obtaining consent was higher in patients with asteatosis, and the proportion of women tended to be higher in healthy adults, patients with asteatosis, and all patients with atopic dermatitis. In terms of the percentage of each lesion site, the right and left forearms (extensor surfaces) and right and left lower legs (anterior and posterior surfaces) tended to have lesions in relatively high percentages (75% or more) in both patients with asteatosis and those with atopic dermatitis. Otherwise, there were no significant biases or differences between groups. None of the study subjects had complications or used concomitant medications or therapies.

This study was conducted at a single institution (Medical Corporation Shinanokai, Shinanozaka Clinic). Consent was obtained from the first case on November 3, 2022, and from November 3, 2022 to February 13, 2023, consent was obtained from a total of 314 cases (70 healthy adults, 155 patients with asteatosis, and 89 patients with atopic dermatitis). Of those who consented, 311 patients underwent pre-testing, and 3 patients (all with atopic dermatitis) did not undergo pre-testing. Eligible subjects were 55 healthy adults, 143 patients with ateatosis and 85 patients with atopic dermatitis. The patients who were ineligible and dropped out of the study were 15 healthy adults, 12 patients with asteatosis, and 1 patient with atopic dermatitis. The observation period ended on 25 February 2023. The study subjects enrolled on the day of measurement by study devices were 40 healthy adults, 120 patients with asteatosis, and 80 patients with atopic dermatitis.15 healthy adults, 23 patients with asteatosis, and 5 patients with atopic dermatitis were determined to be ineligible on the day of measurement and dropped out. Enrollment of 240 study subjects was completed as planned from November 10, 2022 to February 25, 2023. Measurements with the study devices were performed on enrolled subjects and no cases were discontinued. There were no deviations from the study protocol occurred. The enrolled all study subjects were recruited into the efficacy and safety analysis populations.

There were no adverse events or medical device adverse events that occurred in this study.

Summary statistics (mean and median) were calculated for each study group (healthy adults, patients with asteatosis, and patients with atopic dermatitis) by site and ODS for representative values of water content of the stratum corneum (mean and median of three measurements per site) in the efficacy analysis target population. The ODS of the right and left forearms (flexion side), right and left forearms (extension side), right and left lower legs (front and back), and trunk (right and left lower back) were 0 to 3 in patients with asteatosis, and 0 to 4 in patients with atopic dermatitis. ODS 1 to 4 for the left and right lower legs (anterior surface), and ODS 0 to 2, 4 for the trunk (right lower back). For the water content of the stratum corneum by site and ODS for each study group, we compared each mean and each median. As a result, there was no significant difference in water content of the stratum corneum at each site and at each ODS. The variability of water content of the stratum corneum was large, and no consistent trend was obtained for the variation of mean water content of the stratum corneum with increasing ODS. The results of water content of the stratum corneum by ODS without distinguishing between the left and right sides of the body were similar to the results of the primary analysis results (results when differentiating between left and right sides of the site). The results showed that there was no significant difference in water content of the stratum corneum in each site and each pruritus NRS. There was no clear correlation between water content of the stratum corneum and pruritus NRS. Summary statistics (mean and median) were calculated for pruritus NRS in the efficacy analysis population by site and ODS in each study group, there was no clear correlation between ODS and pruritus NRS. Comparison of representative values of water content of the stratum corneum for each severity assessment in patients with atopic dermatitis showed no significant differences in stratum corneum water content for erythema, edema/papule, scratch marks, lichenification, overall severity score, and all atopic dermatitis area and severity indices. The AUC of the receiver operating characteristic (ROC) curve and its optimal cutoff value showed that the cutoff values were close to each other even if the ODS values were different, about the ROC curve for the ability to classify ODS by stratum corneum water content (mean and median) by study group and site in the efficacy analysis population was examined to determine the boundary zone of dry skin conditions. The water content of the stratum corneum of patients with asteatosis in the efficacy analysis population was compared by the presence or absence of erythema at the site of ODS 3. The results showed no significant difference in stratum corneum water content between patients with and without erythema at the ODS 3 site. The results of the study on the method of adopting measurements of stratum corneum water content showed that both the mean and median within each site of measured stratum corneum water content for each study subject and each site did not change in trend. Inter-rater difference analysis of water content of the stratum corneum in the target population, no inter-rater differences in mean and median values of water content of the stratum corneum were considered to exist.

No 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.

Nov. 30, 2023

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs032220396

Tsunemi Yuichiro

Medical Corporation Shinanokai, Shinanozaka Clinic

Yotsuya Medhical Building 3F, 20 Samoncho, Shinjuku-ku, Tokyo

ytsun-tky@umin.ac.jp

Tsunemi Yuichiro

Medical Corporation Shinanokai, Shinanozaka Clinic

Yotsuya Medhical Building 3F, 20 Samoncho, Shinjuku-ku, Tokyo

+81-3-5366-3006

ytsun-tky@umin.ac.jp

Complete

Oct. 19, 2022

Other

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

diagnostic purpose

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

Both

Asteatosis,Atopic dermatitis

Asteatosis,Atopic dermatitis

Relationship between Overall Dry Skin score (ODS) and water content of stratum corneum

-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

+81-3-3470-3360

Sept. 14, 2022

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