Examination of the effects of moisturizers on basal sweating, sebum, and stratum corneum function in patients with sebum deficiency
- Conditions
- asteatosis
- Registration Number
- JPRN-jRCTs031230537
- Lead Sponsor
- Aoyama Yumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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,
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method