Atopic Dermatitis
Conditions
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: 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
Interventions
DRUGMelatonin
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.
DRUGDiphenhydramine
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.
DRUGPlacebos
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.
Sponsors
Children's Hospital and Medical Center, Omaha, Nebraska
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POEM (Patient Oriented Eczema Measure) | 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. |
| EASI score | 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
| Measure | Time frame | Description |
|---|---|---|
| 5D Pruritus survey | 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. |
| ESS-CHAD | 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. |
| Actigraphy | 6 weeks | This device is worn on the wrist of a patient like a watch and records sleep-wake cycles. |
Outcome results
None listed