Treatment of Nighttime Pruritus in Atopic Dermatitis

NCT03688464 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 0197-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (3)

• 5D Pruritus survey

  6 weeks

• ESS-CHAD

  6 weeks

• Actigraphy

  6 weeks

Study Arms (3)

Melatonin Treatment

ACTIVE COMPARATOR

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

Diphenhydramine Treatment

ACTIVE COMPARATOR

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

Drug: Diphenhydramine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Melatonin DRUG

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.

Also known as: generic

Melatonin Treatment

Diphenhydramine DRUG

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.

Also known as: Benadryl

Diphenhydramine Treatment

Placebos DRUG

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.

Also known as: generic

Placebo

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Physician diagnosed eczema covering more than 5% of body surface area
• Ages 2-12 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Children's Hospital and Medical Center, Omaha, Nebraska: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Melatonin; Drugs, Generic; Diphenhydramine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kylie Liermann, DO

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: February 2, 2019
• Primary Completion: February 2, 2019
• Study Completion: February 2, 2019
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share