Treatment of Nighttime Pruritus in Atopic Dermatitis

August 12, 2023 updated by: University of Nebraska

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • generic
Active Comparator: Diphenhydramine Treatment
Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.
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.
Other Names:
  • Benadryl
Placebo Comparator: Placebo
Subjects will receive cherry flavored placebo at bedtime for 4 weeks.
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.
Other Names:
  • generic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POEM (Patient Oriented Eczema Measure)
Time Frame: 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.
6 weeks
EASI score
Time Frame: 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5D Pruritus survey
Time Frame: 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.
6 weeks
ESS-CHAD
Time Frame: 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.
6 weeks
Actigraphy
Time Frame: 6 weeks
This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Children's Hospital and Medical Center, Omaha, Nebraska

Investigators

  • Principal Investigator: Kylie Liermann, DO, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2018

Primary Completion (Actual)

February 2, 2019

Study Completion (Actual)

February 2, 2019

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0197-18-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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