Treatment of Nighttime Pruritus in Atopic Dermatitis

• Status: Withdrawn
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska
• Collaborator: Children's Hospital and Medical Center, Omaha, Nebraska
• Treatments: Diphenhydramine; Melatonin; Promethazine

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