Treatment of Nighttime Pruritus in Atopic Dermatitis

Early Phase 1

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebos; Drug: Melatonin; Drug: Diphenhydramine

• Registration Number: NCT03688464
• Lead Sponsor: University of Nebraska

Brief 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

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Primary Completion: 2019-02-02
• Study Completion: 2019-02-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-12
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Physician diagnosed eczema covering more than 5% of body surface area
• Ages 2-12 years old

Exclusion Criteria

• Sleep disorder, including underlying insomnia
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Subjects will receive cherry flavored placebo at bedtime for 4 weeks.
Melatonin Treatment	Melatonin	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.
Diphenhydramine Treatment	Diphenhydramine	Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.

Primary Outcome Measures

Name	Time	Method
POEM (Patient Oriented Eczema Measure)	6 weeks	This survey is a total of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
EASI score	6 weeks	This tool is also used to assess severity of eczema. 4 different body regions are scored based on the percentage of eczema affecting the area. The calculations for each region are severity score x area score x known multiplier. A higher score indicates a higher severity of disease.

Secondary Outcome Measures

Name	Time	Method
5D Pruritus survey	6 weeks	This survey is a 5 question survey to assess severity of itch in patient's with eczema. The higher the score the worse the pruritus is and the more it affects the patient on a daily basis.
ESS-CHAD	6 weeks	This questionnaire is a series of questions that assesses sleepiness. Patient's can rank the situations based on a 3 point scale, 0 indicating would never doze and 3 indicating a high chance of dozing. A higher score indicates increased sleepiness.
Actigraphy	6 weeks	This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.