asteatosis asteatosis
Conditions
Interventions
asteatosis:Subjects apply the study drug (Hirudoid Cream 0.3% or Propeto (White Petrolatum)) to the entire unilateral lower leg as instructed by the evaluating physician from the start of treatment un
Sponsors
Aoyama Yumi
Mauro Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: asteatosis 1)Persons aged between 20 and 60 years at the time of informed consent. 2)Body Mass Index (BMI) a person whose is 18.5 or more but less than 25.0. 3)Patients with sebum deficiency, with severe dryness of the entire lower legs on the day treatment is started, and with pruritus of the entire lower legs. healthy adults 1)Persons aged between 20 and 60 years at the time of informed consent. 2)Body Mass Index (BMI) a person whose is 18.5 or more but less than 25.0. 3)Persons without evidence of dryness with an average stratum corneum water content of 50 microS or more on the lower legs who do not have pruritus. 4)Persons who have not had abnormal glucose tolerance or renal function detected by medical examination,
Exclusion criteria
Exclusion criteria: asteatosis (1)Patients with any of the following medical histories or following diseases. 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.) 5)Hemorrhagic blood diseases (hemophilia, thrombocytopenia, purpura, etc.) 6)Serious diseases of the heart, liver, kidneys, lungs, and blood that investigator have considered are inappropriate for participate in study. 7)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. 8)Diseases such as hyperhidrosis in which the amount of sweating are not stable. 9)Diabetic (2)Patients with scratches or eczema on the area (lateral lower leg) evaluated in this study. (3)Patients who had a few bleeds might induce serious effect. (4)Patients who have participated in this study. (5)Patient participating in other clinical studies, clinical trials, or post-marketing clinical trials. (6)Patients who used the any topical preparation (including over-the-counter drug, quasi-drugs, cosmetics) for the lower leg evaluated with asteatosis within 14 days before the start of treatment. (7)Patients who have used oral antihistamines or antiallergic medicines within the 14 days before the start of treatment. (8)Patient who used medicine that change sweating within 14 days before the start of treatment (excluding Chinese medicine, including off-label use hyperhidrosis medicine and botulinum toxin therapy. ) (9)Patient who used systemic remedies for skin diseases within 14 days before the start of treatment (10)Patients who have used systemically administered steroids within the 3 months (90 days) before the start of treatment. (11)Patients who is in the situation of pregnancy or breastfeeding or have a possibility of pregnancy (12)Patients who are judged as ineligible for this study by the investigator. healthy adults (1)Patients with any of the following medical histories or following diseases. 1)Serious allergies (shock, anaphylaxis-like symptoms) 2)Serious diseases of the heart, liver, kidneys, lungs, and blood that investigator have considered are inappropriate for participate in study. 3)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. 4)Diseases such as hyperhidrosis in which the amount of sweating and are not stable. 5)Diabetic 6)Asteatosis 7)Atopic dermatitis (2)Patients with scratches or eczema on the area (lateral lower leg) evaluated in this study. (3)Patients who have participated in this study. (4)Patient participating in other clinical studies, clinical trials, or post-marketing clinical trials. (5)Patients who used the any topical preparation (including over-the-counter drug, quasi-drugs, cosmetics) for the lower leg evaluated with asteatosis within 14 days prior to treatment starting date. (6)Patients who have used oral antihistamines or antiallergic medicines within the 14 days preceding the start of treatment. (7)Patient who used medicine that change sweating within 14 days before the start of treatment (excluding Chinese medicine, including off-label use hyperhidrosis medicine and botulinum toxin therapy. ) (8)Patient who used systemic remed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of basal sweating in patients with sebum deficiency by topical preparation Time course of change in basal sweating in patients with sebum deficiency from before treatment by topical preparation Comparison of basal sweating between healthy adults and patients with sebum deficiency | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of basal sweating in stratified patients with sebum deficiency by type of topical preparation Time course of ODS, NRS, water content of stratum corneum, TEWL, sebum content, skin temperature and sebum components, Lamellar liquid crystals, cell area, multiple exfoliation degree and nucleated cell fraction in total and stratified patients with sebum deficiency by topical preparation Time course of change in basal sweating in stratified patients with sebum deficiency from before treatment by topical preparation. Change over time from before treatment time course of ODS, NRS, water content of stratum corneum, TEWL, sebum content, skin temperature and sebum components, Lamellar liquid crystals, cell area, multiple exfoliation degree and nucleated cell fraction in total and stratified patients with sebum deficiency by topical preparation Overall* and stratified differences in basal perspiration, ODS, NRS, water content of stratum corneum, TEWL, sebum content, skin temperature and sebum components, Lamellar liquid crystals, cell area, multiple exfoliation degree and nucleated cell fraction in healthy adults and in patients with sebum deficiency (on the day treatment started) *Only for patients with sebum deficiency Cluster classification by three axes: tarsal sweat droplet count, sulcus sweat droplet count, skin roughness Analysis of sebum components (molecular species) | — |
Contacts
Public ContactYumi Aoyama
Medical Corporation Shinanokai, Shinanozaka Clinic
Outcome results
None listed