NCT01638234

Brief Summary

Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

July 8, 2012

Last Update Submit

April 16, 2015

Conditions

Atopic Dermatitis

Keywords

atopic dermatitiseczema

Outcome Measures

Primary Outcomes (1)

  • Objective sleep measures as measured by actigraphs and SCORAD

    actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment

    4 weeks

Secondary Outcomes (4)

  • urine and serum cytokines

    4 weeks

  • total and allergen-specific IgE

    4 weeks

  • sleep parameters measured by polysomnography

    4 weeks

  • subjective improvement in symptoms

    4 weeks

Study Arms (2)

Starch pill

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Melatonin

EXPERIMENTAL
Dietary Supplement: Melatonin

Interventions

MelatoninDIETARY_SUPPLEMENT

melatonin 3 mg tab 1 tab po hs for 4 weeks

Melatonin
PlaceboDIETARY_SUPPLEMENT

starch pill

Starch pill

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months

You may not qualify if:

  • Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
  • Those who had received therapy for insomnia within 4 weeks before the baseline visit
  • Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
  • Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
  • Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
  • Pregnant and lactating women and those who are presently planning to get pregnant
  • Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Chang YS, Lin MH, Lee JH, Lee PL, Dai YS, Chu KH, Sun C, Lin YT, Wang LC, Yu HH, Yang YH, Chen CA, Wan KS, Chiang BL. Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance: A Randomized Clinical Trial. JAMA Pediatr. 2016 Jan;170(1):35-42. doi: 10.1001/jamapediatrics.2015.3092.

    PMID: 26569624DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jyh-Hong Lee, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2012

First Posted

July 11, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

TW(1)