Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2019-02-02
2019-02-02
Brief Summary
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Detailed Description
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Secondary aims will include:
1. Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
2. Compare differences between treatment groups in disease improvement
3. Compare differences between treatment groups in quality of life
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Melatonin Treatment
Subjects to receive melatonin 0.1 mg/kg (minimum dose of 1 mg, maximum dose of 5 mg) 30 minutes prior to bedtime (1 mg/ml oral compound suspension) for 4 weeks.
Melatonin
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Diphenhydramine Treatment
Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.
Diphenhydramine
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Placebo
Subjects will receive cherry flavored placebo at bedtime for 4 weeks.
Placebos
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Interventions
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Melatonin
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Diphenhydramine
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Placebos
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 2-12 years old
Exclusion Criteria
* Neuropsychiatric disorder
* Condition that requires use of antihistamines
* On systemic eczema therapy or monoclonal antibody for allergic diseases
* Unable to discontinue other antihistamine use
* Autoimmune disease as melatonin is contraindicated
2 Years
12 Years
ALL
Yes
Sponsors
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Children's Hospital and Medical Center, Omaha, Nebraska
OTHER
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Kylie Liermann, DO
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Other Identifiers
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0197-18-FB
Identifier Type: -
Identifier Source: org_study_id
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