Effect of melatonin supplementation in treatment of atopic dermatitis

Clinical trial of the effect of melatonin supplementation on disease severity and sleep quality in children with atopic dermatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017082733941N12

Enrollment

Registered

2017-10-15

Start date

2017-10-13

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis. Atopic dermatitis, unspecified

Interventions

Intervention 1: Intervention group: Melatonin supplements (Webber Naturals, Canada), 3 mg, two sub lingual tablets, one hour before bedtime for 6 weeks. Intervention 2: Control group: Placebo (Barij E

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children diagnosed with atopic dermatitis Children aged 6-12 years

Exclusion criteria

Exclusion criteria: Patients who were receiving any systemic corticosteroid or other immunosuppressive drugs or taking antihistamines within the last 3 months before the study Children diagnosed with acquired immunosuppressive disease Children diagnosed with other chronic conditions

Design outcomes

Primary

Measure	Time frame
SCORAD index. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: physical exmamination by pediatrician.;Objective SCORAD index. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: physical exmamination by pediatrician.	—

Secondary

Measure	Time frame
Pruritus score. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;Sleep-onset latency. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total sleep time. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Children's Sleep Habits Questionnaire score. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Serum total IgE levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Radioimmunoassay.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.	—

Measure

Time frame

Pruritus score. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;Sleep-onset latency. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total sleep time. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Children's Sleep Habits Questionnaire score. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Serum total IgE levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Radioimmunoassay.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Sharif

Kashan University of Medical Sciences

mrsharifmd@yahoo.com+98 31 5554 0026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026