臨床研究等提出・公開システム

Single-center, randomized, single-blind, parallel-group comparative study of investigating the effects of moisturizers on basal sweating and microcirculation in patients with Asteatosis

Examination of the effects of moisturizers on basal sweating and microcirculation in patients with sebum deficiency

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The background of participants in this study is as follows. The number of cases included in the efficacy analysis population was 18 (100.0%) in the Hirudoid cream group and 18 (94.7%) in the Propeto group. One case from the Propeto group was excluded because the amount of the substance applied was less than half of the prescribed amount, which could potentially affect the evaluation of the drug's efficacy. In the Hirudoid cream and Propeto groups (in that order), the average age at the time of consent was 48.2 +/- 10.6 years and 45.5 +/- 12.2 years, respectively. The gender distribution (male/female) was 1 (5.6%) / 17 (94.4%) and 2 (11.1%) / 16 (88.9%) respectively. In both groups, all participants had no previous medical history (0 (0.0%)/18 (100.0%)), and the distribution of participants with or without complications was 9 (50.0%)/9 (50.0%) and 5 (27.8%)/13 (72.2%) respectively. Regarding the presence or absence of lesions in different parts of the body due to the primary disease (present/absent), the distribution was as follows: face 2 (11.1%)/16 (88.9%) and 4 (22.2%)/14 (77.8%), trunk 7 (38.9%)/11 (61.1%) and 7 (38.9%)/11 (61.1%), thigh 3 (16.7%)/15 (83.3%) and 7 (38.9%)/11 (61.1%), lower leg 18 (100.0%)/0 (0.0%) and 18 (100.0%)/0 (0.0%), back 7 (38.9%)/11 (61.1%) and 6 (33.3%)/12 (66.7%), dorsum of foot 3 (16.7%)/15 (83.3%) in both groups, arm 13 (72.2%)/5 (27.8%) and 11 (61.1%)/7 (38.9%), other areas 6 (33.3%)/12 (66.7%) and 5 (27.8%)/13 (72.2%). The distribution of participants with or without a history of treatment for the primary disease (yes/no) was 1 (5.6%)/17 (94.4%) and 0 (0.0%)/18 (100.0%) respectively. The main complications observed were hyperlipidemia and hypertension, each found in 3 participants, and hand dermatitis in 2 participants. The demographic characteristics and other baseline data were similar in both groups.

Out of the 38 participants who consented to this study, 37 were enrolled, while 1 was excluded during the screening phase due to a violation of the exclusion criteria. The 37 enrolled participants were divided into 2 groups: 18 in the Hirudoid cream group and 19 in the Propeto group, and all participants were administered the study drug. None of the participants in either group discontinued the study after receiving the study drug, and all enrolled participants completed the treatment period. At the time of consent, seven participants in the Hirudoid cream group and six in the Propeto group agreed to participate in the post-observation period, and all of these participants completed this period.

There was no disease or the like in this study.

This study was conducted to determine the effects of moisturizers on basal perspiration and microcirculation in patients with moderate to severe asteatosis. At the time of the study design, it was hypothesized that the total number of sweat droplets would be reduced (less than 100 droplets/cm2) in patients with moderate to severe asteatosis. However, the total number of sweat droplets (mean +/- standard deviation) on the start of treatment was 129.4 +/- 37.8 droplets/cm2 and 134.4 +/- 44.7 droplets/cm2 in the Hirudoid cream and Propeto groups, respectively. When the total number of sweat droplets on the start of treatment was divided into those on the crista cutis and sulcus cutis, the number of sweat droplets on the crista cutis in the Hirudoid cream group was 73.2 +/- 40.1 droplets/cm2, and on the sulcus cutis it was 56.2 +/- 29.0 droplets/cm2 (proportion of sulcus cutis: approximately 45%). In the Propeto group, the number of sweat droplets on the crista cutis was 62.1 +/- 32.1 droplets/cm2, and on the sulcus cutis it was 72.3 +/- 30.1 droplets/cm2 (proportion of sulcus cutis: approximately 50%). The average values for sweat droplets on the lower legs of healthy volunteers examined in a previous study were 141 droplets/cm2 overall, 35 droplets/cm2 on the crista cutis, and 106 droplets/cm2 on the sulcus cutis (proportion of sulcus cutis: approximately 75%) (data not shown). This suggests that the patients with asteatosis in this study had a higher proportion of sweat droplets on the crista cutis, indicating the possibility of compensatory sweating. The total number of sweat droplets decreased 1 and 2 weeks after treatment initiation in both the Hirudoid cream and Propeto groups, and no increase in the total number of sweat droplets due to the moisturizer was observed. When Hirudoid cream was applied to the lower legs for 2 weeks, it did not alter the number of sweat droplets (basal perspiration) in the sulcus cutis (from 56.2 +/- 29.0 droplets/cm2 at treatment start to 57.3 +/- 35.2 droplets/cm2 after 2 weeks), and it was thought to suppress sweating from the crista cutis, which was assumed to be compensatory (from 73.2 +/- 40.1 droplets/cm2 at treatment start to 34.4 +/- 40.4 droplets/cm2 after 2 weeks).Furthermore, the proportion of sulcus cutis (mean +/- standard deviation) increased from 45.490 +/- 22.341% at the start of treatment to 64.295 +/- 23.956% after 2 weeks. When Propeto cream was applied to the lower legs for 2 weeks, it suggested a suppression of sweating from both the sulcus cutis (from 72.3 +/- 30.1 droplets/cm2 at treatment start to 51.4 +/- 35.8 droplets/cm2 after 2 weeks) and the crista cutis (from 62.1 +/- 32.1 droplets/cm2 at treatment start to 31.1 +/- 22.0 droplets/cm2 after 2 weeks). However, the proportion of sulcus cutis remained unchanged, from 55.297 +/- 15.833% at the start of treatment to 55.415 +/- 24.835% after 2 weeks. Also, when Hirudoid cream was applied to the lower leg for 2 weeks, the fineness (skin roughness) of the crista cutis and sulcus cutis (mean +/- standard deviation, same hereafter) decreased from 4.44 +/- 0.94 at the start of treatment to 3.94 +/- 1.26 after 2 weeks. The change in skin roughness from the start of treatment was significantly lower in the Hirudoid cream group than in the Propeto group at 1 and 2 weeks after treatment initiation. The ratio of skin roughness to the start of treatment was also significantly lower in the Hirudoid cream group than in the Propeto group 2 weeks after treatment initiation. These results suggest that the application of moisturizers may suppress compensatory sweating of the crista cutis in patients with asteatosis, bringing it closer to normal values, and may have resulted in a decrease in the total number of sweat droplets compared to before treatment. Furthermore, Hirudoid cream may potentially bring the state of basal perspiration and skin roughness of asteatosis patients closer to that of healthy individuals by increasing the proportion of sulcus cutis and reducing skin roughness. In the subpopulation with a low total number of sweat droplets and impaired sweating (less than 100 droplets/cm2) at the start of treatment, the total number of sweat droplets increased from 62.5 +/- 14.8 droplets/cm2 and 67.0 +/- 33.9 droplets/cm2 at the start of treatment in the Hirudoid cream and Propeto groups, respectively, to 75.0 +/- 38.2 droplets/cm2 and 72.0 +/- 26.9 droplets/cm2 after 2 weeks. The mean number of sweat droplets increased after application of the moisturizer. Furthermore, the number of sweat droplets in the sulcus cutis increased after the application of Hirudoid cream (from 39.5 +/- 9.2 droplets/cm2 at the start of treatment to 58.5 +/- 30.4 droplets/cm2 2 weeks later). This suggests that in patients with a low total number of sweat droplets at the start of treatment, Hirudoid cream may promote basal sweating and restore the state of sweat secretion in the sulcus cutis and crista cutis, bringing it closer to that of healthy volunteers. In the subpopulation with a low number of sweat droplets in the sulcus cutis (less than 40 droplets/cm2) at the start of treatment, the number of sweat droplets in the sulcus cutis increased over time (from 21.4 +/- 14.4 droplets/cm2 at the start of treatment to 27.8 +/- 26.0 droplets/cm2 after 1 week and 40.0 +/- 11.2 droplets/cm2 after 2 weeks) following the application of Hirudoid cream. This suggests that in patients with a low number of sweat droplets in the sulcus cutis at the start of treatment, Hirudoid cream may enhance the secretion of basal perspiration, which is primarily secreted in the sulcus cutis. The results of the cluster analysis indicated that the participants in this study could be classified into four distinct clusters. This suggests that there may be four stages of sweating disorder and the fineness of sulcus cutis and crista cutis (skin roughness) in asteatosis. In the subpopulation with the most severe dyshidrosis, a trend towards improvement in the total number of sweat droplets, the number of sweat droplets in the sulcus cutis, and the fineness of sulcus cutis and crista cutis (skin roughness) was observed over time, starting from 1 week after the application of Hirudoid cream. This suggests that this subpopulation may have a relatively high responsiveness to Hirudoid cream.

When Hirudoid cream was applied to the lower legs for 2 weeks, an increase in the sulcus cutis percentage was observed due to the suppression of sweating from the crista cutis. Furthermore, a decrease in the fineness of sulcus cutis and crista cutis (skin roughness) was noted. These findings suggest that Hirudoid cream may gradually bring the state of basal perspiration and skin roughness in patients with asteatosis closer to that of healthy volunteers.

Feb. 29, 2024

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs061210081

Aoyama Yumi

Kawasaki Medical School Hospital

577 Matsushima, Kurashiki City, Okayama

ymaoyama@med.kawasaki-m.ac.jp

Aoyama Yumi

Kawasaki Medical School Hospital

577 Matsushima, Kurashiki City, Okayama

+81-86-462-1111

ymaoyama@med.kawasaki-m.ac.jp

Complete

Mar. 02, 2022

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

(1)Patients who have asteatosis, with no sign of eczema lower leg on the day of the treatment start
(2)Patients 20 years and older at the time of informed consent

(1) Patients with any of the following medical histories
1) Serious allergies (shock, anaphylaxis-like symptoms)
2) Hypersensitivity to heparinoid-containing preparations
3) Hypersensitivity to PROPETO (White Petrolatum)
4) Skin hypersensitivity to topical medicines (contact dermatitis, etc.)
(2) Patients 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 that occur at the evaluation area of this study
4) Diseases such as hyperhidrosis and microcirculatory disorder symptoms in which the amount of sweating and blood flow are not stable
5) Hemorrhagic blood diseases (hemophilia, thrombocytopenia, purpura, etc.)
(3) Patient who are expected to become serious even if they bleed slightly
(4) Patient enrolled in this study in the past
(5) Patient participating in other clinical studies, clinical trials or post-marketing clinical trials
(6) Patient who used topical drugs (including over-the-counter drugs, quasi-drugs, and cosmetics) for the rash on the lower leg with asteatosis within 14 days before the start of treatment
(7) Patient who took oral antihistamine or oral antiallergic drug within 14 days before the start of treatment
(8) Patient who used medicine that change sweating or blood flow within 14 days before the start of treatment (excluding Chinese medicine, including off-label use hyperhidrosis medicine)
(9) Patient who took oral corticosteroids within 3 months (90 days) before the start of treatment
(10) Female patient, who be pregnant or lactating or may be pregnant
(11) COVID-19 patients (including asymptomatic pathogen carriers) or who suspected COVID-19 infection
(12) Patient who were found to have close contact with COVID-19 patients (including asymptomatic pathogen carriers) within 14 days prior to the start of treatment
(13)patient who is judged by the principal investigator or sub- investigator to be ineligible for this study for any other reason

Both

asteatosis

Subjects apply the study drug (Hildoid Cream 0.3% or Propet (White Petrolatum)) to the entire unilateral lower leg as instructed by the evaluating physician from the start of treatment until the time of visit 2 weeks after the start of treatment. If subjects participate in the follow-up period, the study medicine (Hildoid Cream 0.3% or Propet(white petrolatum)) should not be applied to the unilateral lower leg, which is the evaluation area, from the time of the visit 2 weeks later to the time of the visit 3 weeks later.

asteatosis

-Changes over time of basal sweating
-Changes over time in amount of change from before treatment for basal sweating
-Changes over time of blood volume
-Changes over time in amount of change from before treatment for blood volume

-Changes over time of microvascular structure
-Changes over time in amount of change from before treatment for microvascular structure
-Changes over time of overall dry skin score
-Changes over time of pruritus NRS
-Changes over time of water content in the stratum corneum
-Changes over time of TEWL

+81-86-464-1076

Jan. 26, 2022

none