計劃書編號Ver1.0_1080401
尚未開始召募
2019-05-01 - 2021-12-31
Phase I
終止收納1
以外用褪黑激素治療兒童異位性皮膚炎之療效
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試驗委託 / 贊助單位名稱
台北市立聯合醫院
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臨床試驗規模
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更新日期
2026/03/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
適應症
異位性皮膚炎
試驗目的
Topical melatonin has never been tried for treatment of patients with AD. Whether the immunomodulatory and skin-protective effects of topical melatonin could be applied for effective treatment in children with AD is of great interest. Our study aims to evaluate the effectiveness of topical melatonin for the treatment of children with AD.
藥品名稱
主成份
Melatonin
劑型
劑量
10%
評估指標
The primary outcome is the SCORAD index for evaluation of AD disease severity. Secondary outcomes included the objective sleep parameters measured by actigraphy, the patient’s subjective description of the change in sleep and dermatitis severity, quality of life of patients and their family (evaluated by the Children’s Dermatitis Quality of Life Index and the Dermatitis Family Index)
主要納入條件
Patients will be recruited from the pediatric and dermatology outpatient departments of National Taiwan University Hospital and Taipei City Hospital Renai Branch.
Inclusion criteria:
The subject must meet all the criteria listed below both at screening and baseline:
(1) Patients with physician-diagnosed AD involving at least 5% of the total body surface area
(2) Age between 2 and 18 years of age
Exclusion criteria:
(1) Those who failed oral or topical immunosuppressant treatment
(2) Those taking oral immunosuppressants
(3) Those with skin infection or skin disease other than AD
(4) Those with autoimmune disease or endocrine disorders
(5) Those who are pregnant or lactating
(6) Those taking sedative medication or antidepressants
(7) Those with documented sleep disorders such as dyssomnias, parasomnias, and circadian rhythm sleep disorders
(8) Those who were unable to fully cooperate
(9) Those who had any other condition or earlier/current treatment which would render the participant ineligible for the study
Inclusion criteria:
The subject must meet all the criteria listed below both at screening and baseline:
(1) Patients with physician-diagnosed AD involving at least 5% of the total body surface area
(2) Age between 2 and 18 years of age
Exclusion criteria:
(1) Those who failed oral or topical immunosuppressant treatment
(2) Those taking oral immunosuppressants
(3) Those with skin infection or skin disease other than AD
(4) Those with autoimmune disease or endocrine disorders
(5) Those who are pregnant or lactating
(6) Those taking sedative medication or antidepressants
(7) Those with documented sleep disorders such as dyssomnias, parasomnias, and circadian rhythm sleep disorders
(8) Those who were unable to fully cooperate
(9) Those who had any other condition or earlier/current treatment which would render the participant ineligible for the study
主要排除條件
Patients will be recruited from the pediatric and dermatology outpatient departments of National Taiwan University Hospital and Taipei City Hospital Renai Branch.
Inclusion criteria:
The subject must meet all the criteria listed below both at screening and baseline:
(1) Patients with physician-diagnosed AD involving at least 5% of the total body surface area
(2) Age between 2 and 18 years of age
Exclusion criteria:
(1) Those who failed oral or topical immunosuppressant treatment
(2) Those taking oral immunosuppressants
(3) Those with skin infection or skin disease other than AD
(4) Those with autoimmune disease or endocrine disorders
(5) Those who are pregnant or lactating
(6) Those taking sedative medication or antidepressants
(7) Those with documented sleep disorders such as dyssomnias, parasomnias, and circadian rhythm sleep disorders
(8) Those who were unable to fully cooperate
(9) Those who had any other condition or earlier/current treatment which would render the participant ineligible for the study
Inclusion criteria:
The subject must meet all the criteria listed below both at screening and baseline:
(1) Patients with physician-diagnosed AD involving at least 5% of the total body surface area
(2) Age between 2 and 18 years of age
Exclusion criteria:
(1) Those who failed oral or topical immunosuppressant treatment
(2) Those taking oral immunosuppressants
(3) Those with skin infection or skin disease other than AD
(4) Those with autoimmune disease or endocrine disorders
(5) Those who are pregnant or lactating
(6) Those taking sedative medication or antidepressants
(7) Those with documented sleep disorders such as dyssomnias, parasomnias, and circadian rhythm sleep disorders
(8) Those who were unable to fully cooperate
(9) Those who had any other condition or earlier/current treatment which would render the participant ineligible for the study
試驗計畫預計收納受試者人數
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台灣人數
180 人
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全球人數
180 人