Dermatitis. Diseases of the skin and subcutaneous tissue(L00-L99)
Conditions
Interventions
Intervention 1: Intervention group: Patients apply topical cream 6% melatonin twice a day for 3 weeks on their skin lesions. Patients receive routine and main dermatitis treatment regimen. Interventio
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 12 year-old or older patients with dermatitis which has affected at least 5% of whole body. Written informed consent to participate in study
Exclusion criteria
Exclusion criteria: Patients receiving systemic treatment for their dermatitis (exception: antihistamines). Patients receiving sedatives. Patients with history of allergic reactions to Melatonin or other ingredients in creams. If a patient refuses to continue the study at any time after the study started.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion severity in the dermatitis score questionnaire. Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: Severity Scoring of Atopic Dermatitis index (SCORAD) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of itching according to12-Item Pruritus Severity Scale(12-PSS). Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: 12-Item Pruritus Severity Scale(12-PSS).;Pain intensity based on Numeric Rating Scale (NRS). Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: Numeric Rating Scale (NRS).;Insomnia severity based on insomnia severity index (ISI). Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: insomnia severity index (ISI).;Sleep Disorder on the Atopic Dermatitis Sleep Scale (ADSS). Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: Atopic Dermatitis Sleep Scale (ADSS).;Quality of life based on Dermatology Life Quality Index (DLQI). Timepoint: At the beginning of the study and 21 days after starting the topical melatonin cream. Method of measurement: Dermatology Life Quality Index (DLQI). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Daei
Karaj University of Medical Sciences
Outcome results
None listed