Investigation of the effects of medical moisturizers application amount on therapeutic effect

Not Applicable

• Conditions: asteatosis

• Registration Number: JPRN-jRCTs031190200
• Lead Sponsor: Tsunemi Yuichiro

Brief Summary

In this study, even in the low-dose group, continuous application twice a day improved skin symptom during the study period of 4 weeks. From this result, it has been clarified that if high adherence to application can be maintained, it takes time for the effect to become apparent, but the symptoms can be alleviated and cured. In the recommended dose group, skin symptoms improved early after the start of treatment. Even in actual clinical practice, it was considered that the therapeutic effect would appear f

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-04
• Study Completion: 2020-03-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients with asteatosis have Overall Dry Skin Score of 3 (without inflammation) on the lower thigh at the start date of treatment
2) Patients 20-years and older at the time of informed consent

Exclusion Criteria

(1) Patients who had following medical history
1) serious allergies (shock, anaphylaxis)
2) hypersensitivity to the products included Heparinoid
3) skin hypersensitivity to any topical product (e.g. contact dermatitis)
(2) Patients complicated with following disease
1) any severe disease determined by investigator to be unsuitable for the study, e.g. cardiac, liver, kidney, lung, blood,
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 disease except for asteatosis at the skin evaluation area of this study
4) Hemorrhagic blood diseases e.g. hemophilia, thrombocytopenia, purpura
(3) Patients who had a few bleed might induce serious effect
(4) Patients who have participated in this study
(5) Patients who participate in another clinical trial, clinical study, and post-marketing clinical trial
(6) Patients who used the any topical preparation(including over-the-counter drug, quasi-drugs, cosmetics) for the thigh within 14 days prior to treatment starting date
(7) Patients who have used antihistamines or allergy medications within the 14 days preceding the start of treatment
(8) Patients who have used systemically administered steroids within the three months preceding the start of treatment
(9) Patients who is in the situation of pregnancy or breastfeeding or have a possibility of pregnancy
(10) Patients who are judged as ineligible for this study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time course of skin symptoms score(measured by Overall Dry Skin Score)<br>Time course of NRS score for itch<br>Time course of change of the water content of the stratum corneum from treatment start date to each visit

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with skin symptoms score of 0(measured by Overall Dry Skin Score)<br>Proportion of patients who had rescue medication<br>Time course of the water content of the stratum corneum, trans epidermal water loss (TEWL) , pH of skin<br>Time course of change of TEWL, pH of skin from treatment start date to each visit