2020, Volume 8, Issue 3, Pages: 1084-1088  
J. Environ. Treat. Tech.  
ISSN: 2309-1185  
Journal web link: http://www.jett.dormaj.com  
Evaluation of Melatonin Supplementation in  
Children with Atopic Dermatitis at Aboreesh  
Hospital, Egypt  
1
2
3
4
Doaa M. Ali , Marwa M. Saeed , Walaa Ibrahim and Amany S. Elsayed *  
1
MD, Professor of Dermatology, Dermatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt  
2
MD, Assistant professor of Family Medicine, Family Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt  
3
MD, Lecturer of Medical Biochemistry& Molecular biology, Medical Biochemistry and Molecular Biology Department, Faculty of Medicine, Cairo  
University, 11562 Cairo, Eygpt  
4
MSc, Family Medicine specialist, Mitghmer health district, Dakahlia governate, Egyptian Ministry of Health, Egypt  
Received: 25/03/2020  
Accepted: 29/06/2020  
Published: 20/09/2020  
Abstract  
Atopic dermatitis (AD) is a chronic, pruritic, inflammatory skin disease commonly associated with poor sleep efficiency. Lower  
nocturnal melatonin secretion was significantly associated with sleep disturbance in the children with AD, which is a major factor  
leading to an impaired quality of life (QOL). Evaluation of melatonin role in management of AD associated with sleep disorders to  
improve quality of life (QOL). Randomized clinical trial used double blind placebo pre and post experimental for intervention group  
with 43 children in each group who were recruited from dermatology outpatient clinic Aboreesh Hospital. This study included children  
with AD aged from (5-15) years and involving at least five % of total body surface area. Patients were randomly allocated into  
Melatonin group and Placebo group. Full history was taken and full general and dermatological examination using scoring atopic  
dermatitis index were done. Serum melatonin and IgE levels were assessed before and after melatonin supplementation. There was  
significant difference between pre and post regarding serum Melatonin and IgE except in blood level of melatonin in placebo group.  
As regard serum level of melatonin become 14pg/ml while before study was 59 pg /ml. But at placebo group started 25.5pg/ml and  
become 17pg/ml. IgE showed significant difference in pre and post study, as it was 132 before melatonin and become 24 after  
supplementation of melatonin while in placebo group drop from 129 to 27. There was significant improvement in total eczema score in  
post study markedly from 69 to two in Melatonin group and from 72 to three in Placebo group. Melatonin supplementation is a safe  
and effective way to improve the sleep-onset latency and disease severity in children with AD.  
Keywords: Atopic dermatitis, Melatonin, SCORAD, QOL, IgE, Family practice  
Introduction1  
including everyday activities and sleep, and psychosocial  
1
wellbeing. There is not necessarily a direct relationship  
between the severity of the atopic eczema and the impact of  
the atopic eczema on quality of life [5].  
Atopic eczema (atopic dermatitis (AD)) is a chronic  
inflammatory itchy skin condition that develops in early  
childhood in the majority of cases. It is typically an episodic  
disease of exacerbation (may occur as frequently as two or  
three per month) and remissions and in some cases it maybe  
continuous [1]. Health promotion has been defined as “the  
process of enabling people to increase control over their  
health and it determinants, and there by improve their health”.  
One of the most important determinants of quality of life  
Melatonin is the main product secreted by the pineal gland  
during the night it has a great functional versatility including  
the regulation of circadian and seasonal immune responses by  
regulation of the T helper 1& 2 (TH1& 2) balance and  
cytokine production. Effects of melatonin in different  
autoimmune diseases aren’t clear [6]. Melatonin deficiency  
and increase serum IgE play a significant role in the sleep  
disturbance [7]. AD also called in Clinical Medicine atopic  
eczema is an increasing common childhood multi-factorial  
and chronic inflammatory skin disease [8]. The immune-  
pathological basis of AD is complex, butit is known that it is  
mediated by a TH1/TH2 biphasic inflammatory response that  
involves several cytokines, such as IL-4 IL-5, IL-13 and IFN-  
y. Regarding to melatonin and atopic dermatitis a first report  
shown evidences of a dysfunction of the melatonin secretion  
in patients with atopic eczema, possibly due to a partially  
reduced activity of the sympathetic nervous system, which is  
involved in the control of melatonin secretion, it was shown  
an elevation of salivary melatonin in patients with AD. By  
contrary, in the phases of disease outbreaks it has been  
documented a reduction in the serum levels of both melatonin  
and B-endorphin. It has been reported that melatonin  
(
QOL) is coetaneous body image of patient, so skin diseases  
are one of the most important factors which influences on it  
2]. Poor sleep efficiency is common in children with AD and  
[
can be predicted by the Scoring Atopic Dermatitis index.  
Melatonin and IgE might play a role in the sleep disturbance  
[3]. Eczema is known to adversely affect daytime behavior. It  
is unclear whether this is a direct effect or mediated by the  
effect of eczema on sleep quality [4]. Healthcare professionals  
should adopt a holistic approach when assessing a child’s  
atopic eczema at each consultation, taking into account the  
severity of the atopic eczema and the child’s quality of life,  
Corresponding author: Amany S. Elsayed, MSc, Family  
Medicine specialist, Mitghmer health district, Dakahlia  
governate, Egyptian Ministry of Health, Egypt. E-mail:  
amany_salaheldin@hotmail.com.  
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Journal of Environmental Treatment Techniques  
2020, Volume 8, Issue 3, Pages: 1084-1088  
suppresses the development of at dermatitis-like skin lesions.  
It has been shown that melatonin related to the inflammatory  
response associated with contact hypersensitivity and that  
one time per night), difficulty falling asleep after waking up at  
night, or difficulty waking up in the morning. (b) Compliant:  
main symptom that necessitates the medical advice. (c)  
Present history: Onset, course, duration of AD, lesions,  
pattern of spread, symptoms and sleep pattern. (d) Past  
History: development, nutrition, vaccination, disease,  
operations, drugs and exposure to allergen and dietary recall.  
(e) Family History: consanguinity, allergic diseases (skin  
allergy -Bronchial asthma).  
melatonin  
treatment  
attenuated  
the  
delayed-type  
hypersensitivity (DTH) [6]. The use of melatonin is supported  
by National institute for Health and Care Excellence (NICE)  
in their Clinical Guideline on the diagnosis and management  
of chronic fatigue syndrome in children. Within that  
Guideline it stated that melatonin may considered for children  
and young people who have sleep disorder [9].  
2
.7 Clinical Examination  
Full general and dermatological examination was done  
using SCORAD scale which is a useful tool for assessing AD  
widely used, the Sleep Disturbance Scale for Children  
2
Materials and Methods  
2
.1 Study design  
This study is randomized clinical trial used double blind  
(
SDSC) and QOL questionnaire, this questionnaire aims to  
placebo pre and post experimental for intervention group.  
This study was carried out through a period of nine months  
from the 1st of March 2017 to the end of October 2017.  
measure how much skin problem have affect child daily life.  
Scoring system in this study includes Eczema Score Consists  
of three sub score, Extent: After give each affected body part  
its own weighted score summation done, Intensity: give score  
from 0-3) according to degree of intensity then summation,  
Subjective: estimated by patient for sleep loss and irritability  
from 0-10) then summation Final score by (extent /5) +  
(7xintensity)/2) +subjective If <25 mild 25-50 moderate >50  
sever. Quality Scoring system: After summation of each item  
from 0-3) and total score we considered >60% impacted  
Sleep scoring system: After summation of each item (from 1-  
2
.2. Ethical approval  
(
Official permissions were obtained from the family  
medicine department, pediatric department, the director of the  
outpatient clinic and the scientific ethical committee of the  
collage. An informed consent was obtained from every patient  
before filling the questionnaires. They were reassured about  
the strict confidentiality of any obtained information, and that  
the study results would be used only for the purpose of  
research.  
(
(
(
5
) and total score we considered >60% impacted.  
2
.8 Laboratory investigations  
2
.3 Participants  
Eighty-six children were included in this study. Children  
Five-milliliter peripheral venous blood samples were  
withdrawn at 9 A.M. from placebo group and melatonin group  
subjects, then blood was allowed to clot and then centrifuged  
at 8000×g for 5 min to separate the serum which was stored at  
were recruited from dermatology outpatient clinic Aboreesh  
Hospital, Faculty of Medicine, Cairo University in the period  
nine from the 1st of March 2017 to the end of October 2017.  
All included children had AD, skin changes above five % of  
body surface area and sleep insufficiency subjective  
complaint. Children with systemic illness, blood disease,  
hormonal disorders, congenital anomalies and children  
documented sleep disorders or neuro-psychiatric-disorders  
were excluded from the study.  
80 °C until used for estimation of: (a) melatonin level in all  
subjects before and after supplementation by ELISA and (b)  
total serum IgE level in all subjects  
supplementation.  
before and after  
2
.8 Statistical analysis  
Results were expressed as mean ± standard deviation (SD)  
for normally distributed data (Total SCORAD, Quality of life  
score and Sleep disorders score) and median interquartile  
range (IQR) for not normally distributed data (Serum  
Melatonin and IgE). Comparison of different variables  
between groups was performed using unpaired t test in  
normally distributed data (Total SCORAD, Quality of life  
score and Sleep disorders score) or Mann Whitney U test in  
not normally distributed data (Serum Melatonin and IgE).  
Pair-wise comparison (pre- versus post-assessment) within the  
same group for different variables was performed using paired  
t test in normally distributed data (Total SCORAD, Quality of  
life score and Sleep disorders score) or Wilcoxon Sign  
Rank test in not normally distributed data (Serum Melatonin  
and IgE). Statistical Package for Social Sciences (SPSS)  
computer program (version 20 windows) was used for data  
analysis. P value ≤ 0.05 was considered significant and < 0.01  
was considered highly significant.  
2
.4 Sample size& sampling  
As effect size of treated agents' melatonin (18.6%) with  
confidence level 95% and power 80%. sample was 43  
children in each group of total 86 children. Patients were  
randomly allocated into Melatonin group and Placebo group.  
2
.5 Intervention& data collection  
Melatonin three mg/day or placebo were administrated by  
subjects one hour before bed time for four weeks. Placebo  
was manufactured by the same drug company manufacturing  
melatonin. Dosage was once daily for four weeks. Patient  
arranged by electronic coding each patient in each group  
represented by number. Melatonin and placebo were arranged  
by a pharmacist coding all the container by specific number  
and letter coding only was known by him. At the end of the  
result he translates the coding. There was no drop out. All the  
children patients were submitted to the following after  
parental approval:  
3
Results  
2
.6 A structured interviewing questionnaire  
a) Personal history: name, age, sex, residence. Level of  
The present study included 86 subjects that were divided  
(
into two groups: placebo group (n=43) and melatonin group  
(n = 43). Age of patients ranged from 5 to 15 with a mean of  
5.23 and 5.46 years respectively, Placebo group included 18  
(41.9%) males and 25 (58.1%) females and the melatonin  
group included 24 (55.8%) males and 19 (144.2%) females.  
There were no significant differences between the placebo  
group and melatonin group regarding age and sex (P = 0.12, P  
consciousness, appearance (color) and vital signs subjective  
symptoms of sleep disturbances children and parents (main  
care giver) completed pediatric sleep evaluation questionnaire  
to evaluate subjective symptoms of sleep disturbances the  
questions included problems with sleep initiation. (Taking 30  
minutes to fall asleep) or maintenance (waking up for at least  
1
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Journal of Environmental Treatment Techniques  
2020, Volume 8, Issue 3, Pages: 1084-1088  
=
0.19) respectively (Table 1). The Total SCORAD, Quality  
of life score, Sleep disorders score, Serum Melatonin and  
IgE showed a highly significant reduction (P = 0.001) within  
both groups, while it showed non-significant differences  
between both groups post- Supplementation (P >0.05).  
Comparing both groups pre- Supplementation revealed a  
statistically highly significant increase in Serum Melatonin (P  
human patients with AD were so limited studies from 2012 up  
tell now. The present study aimed to evaluate role of  
melatonin in treatment of AD associated with sleep disorders  
in children between (5-15) years. At the same time the present  
study showed impaction of atopic eczema on QOL