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Treatment of Nighttime Pruritus in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03688464
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Children's Hospital and Medical Center, Omaha, Nebraska
Information provided by (Responsible Party):
Kylie Liermann, University of Nebraska

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Melatonin Drug: Diphenhydramine Drug: Placebos Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : June 30, 2019


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.

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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Actigraphy [ Time Frame: 6 weeks ]
    This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688464


Contacts
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Contact: Kylie Liermann, DO 402-619-9157 kylie.liermann@unmc.edu
Contact: Hana Niebur, MD hana.niebur@unmc.edu

Sponsors and Collaborators
University of Nebraska
Children's Hospital and Medical Center, Omaha, Nebraska
Investigators
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Principal Investigator: Kylie Liermann, DO University of Nebraska

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Responsible Party: Kylie Liermann, Pediatric Resident, University of Nebraska
ClinicalTrials.gov Identifier: NCT03688464     History of Changes
Other Study ID Numbers: 197-18-FB
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Melatonin
Diphenhydramine
Promethazine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents