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Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Melatonin

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Starch pill

Melatonin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

urine and serum cytokines

serum levels of melatonin, urinary levels of 6-hydroxymelatonin sulfate, and serum levels of cytokines associated with sleep regulation including IL-10, IL-6, IL-4, IL-1b, and IL-31

total and allergen-specific IgE

total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB

sleep parameters measured by polysomnography

sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index

subjective improvement in symptoms

subjective assessment of whether sleep and dermatitis improved after treatment

Full Information

NCT ID

NCT01638234

First Posted

July 8, 2012

Last Updated

April 16, 2015

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01638234

Brief Title

Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Official Title

Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Starch pill

Arm Type

Placebo Comparator

Arm Title

Melatonin

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Melatonin

Intervention Description

melatonin 3 mg tab 1 tab po hs for 4 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

starch pill

Primary Outcome Measure Information:

Title

Objective sleep measures as measured by actigraphs and SCORAD

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

urine and serum cytokines

Description

serum levels of melatonin, urinary levels of 6-hydroxymelatonin sulfate, and serum levels of cytokines associated with sleep regulation including IL-10, IL-6, IL-4, IL-1b, and IL-31

Time Frame

4 weeks

Title

total and allergen-specific IgE

Description

total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB

Time Frame

4 weeks

Title

sleep parameters measured by polysomnography

Description

sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index

Time Frame

4 weeks

Title

subjective improvement in symptoms

Description

subjective assessment of whether sleep and dermatitis improved after treatment

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jyh-Hong Lee, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26569624

Citation

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.

Results Reference

derived

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Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

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