search
Back to results

Treatment of Nighttime Pruritus in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Melatonin
Diphenhydramine
Placebos
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Melatonin Treatment

    Diphenhydramine Treatment

    Placebo

    Arm Description

    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.

    Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.

    Subjects will receive cherry flavored placebo at bedtime for 4 weeks.

    Outcomes

    Primary Outcome Measures

    POEM (Patient Oriented Eczema Measure)
    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
    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

    5D Pruritus survey
    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
    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
    This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.

    Full Information

    First Posted
    September 26, 2018
    Last Updated
    August 12, 2023
    Sponsor
    University of Nebraska
    Collaborators
    Children's Hospital and Medical Center, Omaha, Nebraska
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03688464
    Brief Title
    Treatment of Nighttime Pruritus in Atopic Dermatitis
    Official Title
    Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never started
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    February 2, 2019 (Actual)
    Study Completion Date
    February 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska
    Collaborators
    Children's Hospital and Medical Center, Omaha, Nebraska

    4. Oversight

    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

    5. Study Description

    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: Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis Compare differences between treatment groups in disease improvement Compare differences between treatment groups in quality of life

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Melatonin Treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Diphenhydramine Treatment
    Arm Type
    Active Comparator
    Arm Description
    Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive cherry flavored placebo at bedtime for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Melatonin
    Other Intervention Name(s)
    generic
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Diphenhydramine
    Other Intervention Name(s)
    Benadryl
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    generic
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    POEM (Patient Oriented Eczema Measure)
    Description
    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.
    Time Frame
    6 weeks
    Title
    EASI score
    Description
    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.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    5D Pruritus survey
    Description
    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.
    Time Frame
    6 weeks
    Title
    ESS-CHAD
    Description
    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.
    Time Frame
    6 weeks
    Title
    Actigraphy
    Description
    This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kylie Liermann, DO
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Nighttime Pruritus in Atopic Dermatitis

    We'll reach out to this number within 24 hrs