Treatment of Nighttime Pruritus in Atopic Dermatitis

University of Nebraska

Status and phase: Withdrawn; Early Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Melatonin; Drug: Placebos; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT03688464

0197-18-FB

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 3 patient groups, including a placebo group

Melatonin Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin

Diphenhydramine Treatment

Active Comparator group

Description:

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

Treatment:

Drug: Diphenhydramine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos