NCT03688464

Treatment of Nighttime Pruritus in Atopic Dermatitis

Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.

Detailed description

This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis. 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

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2019-02-02
• Primary completion: 2019-02-02
• Completion: 2019-02-02
• First posted: 2018-09-28
• Last updated: 2024-09-03

Regulatory

• FDA-regulated drug study