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

JRCT ID: jRCTs031190200

Registered date:04/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: asteatosis
• Date of first enrollment: 15/02/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

0.5g or 1.5g of Hirudoid cream 0.3% given to the left or right side of lower thigh where is instructed by the investigator twice daily in the morning and evening after bathing(if patients don't take the bath,they give the study drug before go to bed)for 4 weeks.
If an eczema occur in the skin evaluation area during the study,topical steroid may be applied by the investigator's judgment.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tsunemi Yuichiro
• Source(s) of Monetary Support: Maruho Co.,Ltd