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Treatment of Nighttime Pruritus in Atopic Dermatitis

NCT03688464 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-09-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital and Medical Center, Omaha, Nebraska

    collaborator OTHER

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Kylie Liermann, DO · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-02
Primary Completion
2019-02-02
Completion
2019-02-02
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688464 on ClinicalTrials.gov