JPRN-jRCTs031230537招募中Unknown
Examination of the effects of moisturizers on basal sweating, sebum, and stratum corneum function in patients with sebum deficiency
Aoyama Yumi0 个研究点目标入组 80 人开始时间: 2023年12月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 60age old（—）
- 性别
- All
入选标准
- •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,
排除标准
- •(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
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