Treatment of Nighttime Pruritus in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03688464
• Other study ID #: 0197-18-FB
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 1, 2018
• Est. completion date: February 2, 2019

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2, 2019
• Est. primary completion date: February 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Children's Hospital and Medical Center, Omaha, Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Actigraphy	This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.	6 weeks