Optic

ID

Name

0197-18-FB

Description

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

Trial arms

Trial start

2018-04-01

Estimated PCD

2019-02-02

Trial end

2019-02-02

Status

Withdrawn

Phase

Early phase I

Treatment

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.

Arms:

Melatonin Treatment

Other names:

generic

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.

Arms:

Diphenhydramine Treatment

Other names:

Benadryl

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.

Arms:

Placebo

Other names:

generic

Primary endpoint

POEM (Patient Oriented Eczema Measure)

6 weeks

EASI score

6 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-08-15

Organization

University of Nebraska

Product

Indication

Product

Product

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