Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers: A Quasi-Experimental Trial
Phase: NA
Conditions: Diaper Rash
Sponsor: Jordan University of Science and Technology

 
 
 
 
 
Effects of Argan Spinosa Oil in the Treatment of Diaper 
Dermatitis in Infants and Toddlers: A Quasi-Experimental 
Trial 
 
 
Study Date:  
1- February- 2018 Till 1-June-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Results 
4.1 Introduction 
This study aimed to compare the effect of the traditional medicinal product of Argan 
Spinosa Oil on the speed up of the healing process and alleviation of the symptoms with that 
of topical hydrocortisone ointment on cases of DD among Jordanian infants and toddlers 
younger than two years old. This chapter provides study findings including mother-child 
sociodemographic, the rate of improvement between treatment groups during the trial and 
potential associated risk factors with diaper dermatitis. 
 
4.2 Study Sample Characteristics at Baseline  
As reported previously, the main eligibility criteria for children in this study was that 
children having symptoms of DD in both genders, aged younger than two years. They were 
hospitalized at the time of data collection in pediatric floors at the selected hospitals, 
outpatient children who were attended to their pediatric clinics and children who attended 
affiliated health care centers of JMOH.  
Therefore, the number of children who met the eligibility criteria and agreed to 
participate in the study was 140 (87.5%) out of 160 children. Children were divided equally 
and randomly into two groups (70 children received hydrocortisone ointment and 70 
received the Argan Spinosa Oil).  
The overall loss in home follow-up visits was 20 (12.5%); 9 children from the Argan 
Oil group and 11 children from the hydrocortisone group. There are many reasons for non-
participation of these caregivers of children such as poor compliance to the treatment 
protocol, they did not answer their phone to complete the scheduled visits and loss the 

follow-up procedure, and their unwillingness to participate in the study after the initial 
assessment. 
 
4.2.1 Socio-Demographic Characteristics of Mothers 
Median used in description of the continuous variables which is much more 
representative for skewed distributions to derive at central tendency of the sample set. 
Proportions and percentage used in description of categorical variables. 
A total of 140 mothers with a median age at the time of the study was 28 years (IQR, 
23-33 years) were involved. Among all mothers, 133 (95%) were Jordanians. Majority of 
mothers 98 (70%) were resident in urban areas. Almost two thirds of mothers 102 (72.9%) 
had nuclear family. Most of the mothers 90 (64.3%) had educational qualification of high 
school or higher. About one-fifth of mothers 28 (20%) were primipara mothers. Most of the 
mothers 117 (83.6%) had previous experience of caring of children with diaper dermatitis.  
One-fifth of mothers 31 (22.1%) were employed and earn money. In regard to the 
mothers’ spouse/partners occupation, the mothers were requested to indicate the total 
household monthly income and the percentage was 62 (44.3%), 47 (33.6%) and 22.1 (22.1%) 
had ≤ 300, 301-500, and ≥ 501 Jordan Dinars respectively. 
However, 62 (44.3%) of mothers have received information regarding prevention & 
management of DD mainly from the family member, 54 (38.6%) from health professionals, 
11 (7.9%) from media, and 13 (9.3%) from their experience. 
Moreover, mothers’ demographic baseline characteristics were similar in both study 
groups at the baseline day of the study as reflected in (Table 1). The study findings retain 
the null hypothesis (no difference) for the assumption of homogeneity of variance and 
conclude that there is not a significant difference between the three group’s variances with 
the exception of employment status, which was higher in the Argan Oil group (p < .025), 

and previous experience of mothers with DD which was higher in the hydrocortisone group 
(p < .040). 
 
4.2.2 Socio-Demographic Characteristics of Children 
As mentioned earlier in Table 1, one hundred forty infants and toddlers were 
participated in the study with approximately 31 (44.3%) males in Argan Oil group and 39 
(55.7%) males in hydrocortisone group. They were aged 14 months of median age (IQR, 6-
18 months). Median weight of them was 10 kilograms (IQR, 7.3-12 kilograms). Fifty-eight 
(41.4%) were breastfeed at time of data collection. 
In specific, DD was reported among 138 (98.6%) children using disposable diapers 
exclusively. Median Days of recent DD episode were 3 days (IQR, 2-4 days). 
However, a median of stool frequency was reported 2 times per day (IQR, 1-3 times). 
The water-soaked wipe was used to clean the diaper area was in 51 (36.4 %) of children, 
whereas 49 (35%) used Alcohol wipes and 40 (28.6%) had never used any type of wipes. 
Also, half of the mothers (55%) used soap to clean the diaper area. In addition, most of the 
mothers 113 (80.7%) reported changing diapers < 6 times per day. Also, 88 (62.9%) of 
mothers did bath ≤ 1 times per week. 
Furthermore, about 63 (45%) children who were exposed for air every day developed 
DD. Aeration was done by leaving the child without diaper at home for at least 10 minutes.  
A total of 46 (32.9%) parents applied cream barriers to prevent diaper dermatitis 
occurrence 29 (41.4%) of mothers in the Argan Oil group and 17 (24.3%) in the 
hydrocortisone group). Moreover, no infants and toddlers has diarrhea or receiving 
antibiotics at the time of the data collection. 
Infants’ demographic baseline characteristics were similar in both study groups at the 
baseline day of the study (Table 1). The study findings retain the null hypothesis (no 
difference) for the assumption of homogeneity of variance and conclude that there is not a 

significant difference between the three group’s variances. with the exception of using 
barrier cream, which was more frequently used in the Argan oil group (p < .031). 
 
Table 1: Demographic characteristics of the study child mother pairs participants by study 
groups at baseline day 
Characteristics 
Total 
(N=140) % 
Intervention 
(n=70) % 
Control 
(n=70) % 
p-
Value* 
Sociodemographic Mother Child Pairs 
 
 
 
 
Mother 
 
 
 
 
**Mother Age, years, median (IQR) 
28 (23,33) 
28.5 (23.8,33) 
27 (23,32) 
.137 
Nationality, Jordanian, (n) % 
(133) 95% 
(67) 95.7% 
(66) 94.3% 
1.0 
Residence, Urban, (n) % 
(98) 70% 
(54) 77% 
(44) 62.9% 
.065 
Type of family, Nuclear family, (n) % 
(102) 72.9% 
(54) 77.1% 
(48) 68.6% 
.254 
Educational Status, High school or 
higher, (n) % 
(90) 64.3% 
(49) 70% 
(41) 58.6% 
.158 
Employment, yes, (n) %                       
(31) 22.1% 
(21) 30% 
(10) 14.3% 
.025 
 Income, Jordanian Dinar, (n) % 
 
 
 
 
 
≤ 300 
(62) 44.3% 
(26) 37.1% 
(36) 51.4% 
.229 
301-500 
(47) 33.6% 
(26) 37.1% 
(21) 30% 
 
≥ 501  
(31) 22.1% 
(18) 25.7% 
(13) 18.6% 
 
Parity, primi-parous, (n) % 
(28) 20% 
(18) 25.7% 
(10) 14.3% 
.091 
Child 
 
 
 
 
Child Sex, male, (n) %                               
(70) 50% 
(31) 44.3% 
(39) 55.7% 
0.176 
**Child age, months,median (IQR) 
14 (6,18) 
14 (5,18) 
14 (7.8,19) 
.242 
**Child weight, kilograms, median 
(IQR) 
10 (7.3,12) 
10 (7.2,12) 
10 (7.4,12) 
.967 
Associated factors of incidence DD 
 
 
 
 
Breastfeeding, yes, (n) % 
(58) 41.4% 
(28) 40% 
(30) 42.9% 
.731 
Type of Diaper, Disposable diapers, (n) 
% 
(138) 98.6% 
(69) 98.6% 
(69) 98.6% 
1.0 

Characteristics 
Total 
(N=140) % 
Intervention 
(n=70) % 
Control 
(n=70) % 
p-
Value* 
Type of wipes, (n) % 
 
 
 
 
Wet wipes 
(51) 36.4% 
(31) 44.3% 
(20) 28.6% 
.152 
Alcohol wipes 
(49) 35% 
(21) 30% 
(28) 40% 
 
Never used 
(40) 28.6% 
(18) 25.7% 
(22) 31.4% 
 
Previous experience, yes, (n) % 
(117) 83.6% 
(54) 77.1% 
(63) 90% 
.040 
Frequency of diaper changing, (n) % 
 
 
 
 
< 6 times per day 
(113) 80.7% 
(56) 80% 
(57) 81.4% 
.83 
≥6 times per day 
(27) 19.4% 
(14) 20.3% 
(13) 18.6% 
 
Barrier cream, yes, (n) % 
(46) 32.9% 
(29) 41.4% 
(17) 24.3% 
.031 
Soap, multiple times per day, (n) % 
(77) 55% 
(39) 55.7% 
(38) 54.3% 
.865 
Exposure to air, yes, (n) % 
(63) 45% 
(36) 51.4% 
(27) 38.6% 
.126 
**Stool frequency, times per day, 
median (IQR) 
2 (1,3) 
2 (1,3) 
2 (1,3) 
.844 
Bathing, (n) % 
 
 
 
 
≤ 1 times per week 
(88) 62.9% 
(40) 57.1% 
(48) 68.6% 
.162 
 1 times per week                                
(52) 37.1% 
(30) 42.9% 
(22) 31.4% 
 
**Days of DD episode, days, median 
(IQR)    
3 (2,4) 
3 (2,4.3) 
3 (2,4) 
.95 
Source of information, (n) % 
 
 
 
 
Family member  
Health professional 
(62) 44.3% 
38.6 (54) 
(34) 48.6% 
32.9 (23) 
(28) 40% 
(31) 44.3% 
.466 
Media 
(11) 7.9% 
(5) 7.1% 
(6) 8.6% 
 
Others 
(13) 9.3% 
(8) 11.4% 
(5) 7.1% 
 
* Comparisons have been made using Fisher’s exact test or Person Chi-square test for categorical 
variables. 
** Comparisons have been made using Mann–Whitney U test for continuous variables. 
 
 
 

4.3 Rate of Improvement in Both Groups 
1- What is the effect of the traditional medicinal product of Argan Spinosa Oil among infants 
and children with diaper dermatitis on speed up the healing process and alleviation the 
symptoms of DD, compared to conventional topical steroid ointment? 
Table 2 shows number, score of DD and improvement rates in both study groups 
according to Davis et al., a five-point scale measuring rash severity. Treatment effects (total 
scores) were improved markedly in total scores during first, third and seventh day of trial for 
both study groups. Medication was applied four times per day for both study groups. 
Caregivers were instructed not to apply any on the affected area such as wet wipes, essence 
contained soaps, barrier cream or other medications during days of the trail. 
The assessment of DD scores for each study group at the baseline day were similar in 
DD scores as in the used scale, In the Argan Oil group, 32.9% of children had dermatitis 
with mild irritation compared to 30% in the hydrocortisone group; 31.4% of children had 
dermatitis with moderate irritation compared to 22.9% in the hydrocortisone group; 12.9% 
of children had dermatitis with moderate to severe irritation compared to 15.7% in the 
hydrocortisone group and 22.9% of children had dermatitis with extreme irritation compared 
to 31.4% in the hydrocortisone group. 
The assessment of DD scores for each study group at the first day of treatment have 
shown less DD scores in the Argan Oil group than hydrocortisone group in DD scores as in 
the used scale. In particular, in the Argan Oil group, 8.6% of children had non irritation 
compared to 2.9% in the hydrocortisone group; 52.9% of children had dermatitis with mild 
irritation compared to 45.7% in the hydrocortisone group; 24.3% of children had dermatitis 
with moderate irritation compared to 20% in the hydrocortisone group; 11.4% of children 
had dermatitis with moderate to severe irritation compared to 24.3% in the hydrocortisone 
group and 2.9% of children had dermatitis with extreme irritation compared to 7.1% in the 
hydrocortisone group.  

The assessment of DD scores for each study group at the third day of treatment have 
shown less DD scores in the Argan Oil group than the hydrocortisone group in DD scores 
as in the used scale. In the Argan Oil group, 67.1% of children had non irritation compared 
to 45.7% in the hydrocortisone group; 21.4% of children had dermatitis with mild irritation 
compared to 40% in the hydrocortisone group; 7.1% of children had dermatitis with 
moderate irritation compared to 12.9% in the hydrocortisone group; 1.4% of children had 
dermatitis with moderate to severe irritation compared to 1.4% in the hydrocortisone group 
and 2.9% of children had dermatitis with extreme irritation compared to 0% in the 
hydrocortisone group.  
The assessment of DD scores for each study group at the seventh day of treatment was 
approximately similar in DD scores as in the used scale. In the Argan Oil group, 95.7% had 
non irritation compared to 98.6% in the hydrocortisone group; 1.4% had dermatitis with mild 
irritation compared to 1.4% in the hydrocortisone group; 0% had dermatitis with moderate 
irritation compared to 0% in the hydrocortisone group; 0% had dermatitis with moderate to 
severe irritation compared to 0% in the hydrocortisone group and 2.9% had dermatitis with 
extreme irritation compared to 0% in the hydrocortisone group. 
 

Table 2: Rate of Improvement Between Groups on the Baseline, First, Third, and Seventh Day of treatment 
Rate of healing 
Baseline Day 
First Day 
Third day 
Seventh day 
Argan Oil 
(n = 70) 
Cortisone* 
(n = 70) 
Argan Oil 
(n = 70) 
Cortisone* 
(n = 70) 
Argan Oil 
(n = 70) 
Cortisone* 
(n = 70) 
Argan Oil 
(n = 70) 
Cortisone* 
(n = 70) 
Normal skin 
0 (0) 
0 (0) 
6 (8.6) 
2 (2.9) 
47 (67.1) 
32 (45.7) 
67 (95.7) 
69 (98.6) 
Mild irritation  
23 (32.9) 
21 (30) 
37 (52.9) 
32 (45.7) 
15 (21.4) 
28 (40) 
1 (1.4) 
1 (1.4) 
Moderate irritation  
22 (31.4) 
16 (22.9) 
17 (24.3) 
14 (20) 
5 (7.1) 
9 (12.9) 
0 (0) 
0 (0) 
Moderate- severe irritation  
9 (12.9) 
11 (15.7) 
8 (11.4) 
17 (24.3) 
1 (1.4) 
1 (1.4) 
0 (0) 
0 (0) 
Extreme irritation   
16 (22.9) 
22 (31.4) 
2 (2.9) 
5 (7.1) 
2 (2.9) 
0 (0) 
2 (2.9) 
0 (0) 
**P Value 
.026 
0.000 
0.000 
0.000 
a Values are expressed as No. (%). 
b No significant side effects were observed in both study groups. 
*Cortisone, hydrocortisone 1% group. 
** Person Chi-square test 
 

As shown in the ordinal logistic regression analysis using Generalized Estimating Equations 
(GEE) models revealed a significant overall the potential confounders effect: the factors of time, 
use barrier care, maternal employment status and previous experience of DD. However, infants 
and toddlers in Argan Oil group about .25 times less likely to have higher grade (score intensity) 
of DD compared to infants and toddlers in the hydrocortisone group with (P< .025).  
 
4.4 Rate of Diaper Dermatitis Intensity Scores in Both Groups 
1- What is the effect of the traditional medicinal product of Argan Spinosa Oil among infants and 
children with diaper dermatitis on speed up the healing process and alleviation the symptoms 
of DD, compared to conventional topical steroid ointment? 
In the Argan Oil group, the DD severity score has decreased in the first day of treatment by 
8.6% of children have been none irritation compare to 2.9% in the hydrocortisone group. In the 
Argan Oil group, the DD severity score has decreased in the third day of treatment by 67.1% of 
children have been none irritation compared to 45.7% in the hydrocortisone group. In the Argan 
Oil group, the DD severity score has decreased in the seventh day of treatment by 95.7% of 
children have been none irritation compared to 98.6% in the control group (see Figure 1). 
Mann–Whitney U test indicated that the mean days of disappearing symptoms of infants and 
toddlers were higher in the hydrocortisone group (Median= 3.34) compared to the Argan Oil group 
(Median= 2.75), U= 1810.50, p = .006. A Chi-square test indicated in the Argan Oil group had 
faster onset of recovery in the first 12 hours compared to the hydrocortisone group, χ2 (1, n = 140) 
= .00, p = .000. No side effects were observed and well tolerated in both study groups. 
 
 
 

Table 3: Rate of DD Intensity over time in both study groups 
 
Number 
of cases 
Intensity 
of DD in 
base line 
Intensity 
of DD in 
Day 1 
Intensity 
of DD in 
Day 3 
Intensity 
of DD in 
Day 7 
Argan oil 
70 
100% 
64 (91.4%) 
23 (32.9%) 
3 (4.3%) 
Hydrocortisone 
70 
100% 
68 (97.1%) 
38 (54.3%) 
1 (1.4%) 
 
 
Figure 1: Rate of Diaper Dermatitis Intensity over time in the Study Groups (higher scores indicate 
severe Diaper Dermatitis) 
 
4.5 Predictors of Diaper Dermatitis 
2- What are factors associated with occurrence of DD on infants and children? 
In order to determine possible factors that may contribute to the development of diaper 
dermatitis among Jordanian infants and toddlers, multiple ordinal logistic regression analysis was 
applied on the total sample (140). 
In the multiple ordinal logistic regression models, DD  grade in the assessment day served 
as the dependent variable. The independent variables entered in the model as potential predictors 

based on the mother’s answers on specific questions in the child history checklist were: Mother 
Age, Nationality, Educational Status, Residence, Type of family, Employment, Income, Parity, 
Child Sex, Child age, type of feeding (Breastfeeding), Type of wipes, Previous experience, use 
Barrier cream, use soap, Exposure the area to air, and frequency of bathing. 
As reflected in table 2, the Univariate analysis showed that DD was significantly associated 
with two of the 17 factors considered: use the barrier cream and frequency of bathing/showering 
≤ 1 times per week (P < 0.05 for all comparisons; Table 2). 
The use of the barrier cream (OR=.52; 95% CI = .27-.99; p=.047) is a protective factor 
against the development of DD. Therefore, children of mother’s use barrier cream about .52 times 
less likely risk to develop DD compared to children of mothers who did not use the barrier cream. 
In other words, children who were applied barrier cream were less likely to develop DD. 
On the other hand, the effect of frequency of bathing/showering ≤ 1 times per week 
(OR=2.01; 95% CI = 1.07-3.75; p=.029) was associated with a higher risk of developing of DD. 
Therefore, children of mothers were of bathing/showering ≤ 1 times per week about 2.01 times 
more likely risk to develop DD compared to children of mothers were of bathing/showering ≥ 1 
times per week. 
However, upon fitting these factors using multiple ordinal logistic regression and by 
specifying ‘backward conditional’ method with removal at correlated p < 0.05. Two (2) factors 
including use the barrier cream and frequency of bathing/showering ≤ 1 times per week tested. 
However, use the barrier cream (OR=.35; 95% CI = .18-.72; p=.004) and frequency of 
bathing/showering ≤ 1 times per week (OR=1.15; 95% CI = .65-2.10; p=.002) remained 
significantly associated with diaper dermatitis (Table 2). 
 

Table 4: Summary of the factors that were found on univariate and multivariate logistic regression 
analysis to be significantly associated with diaper dermatitis 
Characteristics 
Univariate 
Multivariate 
OR 
95% CI 
p-value 
OR 
95% CI p-value 
Sociodemographic mother child pairs 
 
Mother 
 
 
 
 
 
 
Mother Age (years) 
1.01 
.97-1.07 
.58 
 
 
 
Nationality, Jordanian 
1.09 
.28-4.29 
.90 
 
 
 
Educational Status, High school 
or higher 
.60 
.32-1.12 
.11 
 
 
 
Residence, Urban 
.72 
.38-1.39 
.33 
 
 
 
Type of family, Nuclear family 
.68 
.32-1.43 
.31 
 
 
 
Employment, employed 
1.01 
.49-2.07 
.98 
 
 
 
Income, Jordan Dinar 
 
 
 
 
 
 
≤ 300 
1.12 
.51-2.43 
.78 
 
 
 
301-500 
.75 
.33-1.69 
.49 
 
 
 
≥ 501 
 
 
 
 
 
 
Parity, Primiparuos 
.63 
.30-1.34 
.23 
 
 
 
Child 
 
 
 
 
 
 
Child Sex, male 
1.18 
.65-2.15 
.58 
 
 
 
Child age 
 
 
 
 
 
 
≤ one year age 
 
 
 
 
 
 
Associated Factors of Incidence DD 
 
 
 
Breastfeeding, yes 
1.62 
.88-2.98 
.12 
 
 
 
Type of wipes 
 
 
 
 
 
 
Wet wipes 
.60 
.28-1.27 
.18 
 
 
 
Alcohol wipes 
1.08 
.51-2.28 
.85 
 
 
 

Characteristics 
Univariate 
Multivariate 
OR 
95% CI 
p-value 
OR 
95% CI p-value 
Never used 
 
 
 
 
 
 
Previous experience, yes 
.78 
.35-1.75 
.55 
 
 
 
Frequency of diaper changing 
 
 
 
 
 
 
< 6 times per day 
       
.81 
.38-1.73 
.59 
 
 
 
Barrier cream, yes 
.52 
.27-.99 
.047 
.35 
.18-.72 
.004 
Soap, multiple times per day 
1.24 
.68-2.25 
.49 
 
 
 
Exposure to air, yes 
1.01 
.56-1.85 
.97 
 
 
 
Bathing 
 
 
 
 
 
 
≤ 1 times per week 
2.01 
1.07-3.75 
.029 
1.15 
.18-.69 
.002 
Dependent Variable: diaper dermatitis score in the assessment day. OR, odds ratio; CI, confidence 
interval. 
 
4.6 Summary 
This chapter provides study findings including mother-child sociodemographic, the rate of 
improvement between treatment groups during the trial and potential associated risk factors with 
diaper dermatitis. Ordinal logistic regression analysis using Generalized Estimating Equations 
(GEE) models was used to describe the changes over the time during trial period and the results 
showed a statistical significant difference (p < 0.05). Infants and toddlers in Argan Oil group about 
.25 times less likely to have higher grade (score intensity) of DD compared to infants and toddlers 
in the hydrocortisone 1% group with (P< .025). Univariate and multivariate ordinal logistic 
regression model was conducted to identify the main predictors that may contribute to the 
development of DD among Jordanian infants and toddlers after controlling the confounders. use 
the barrier cream (OR=.35; 95% CI = .18-.72; p=.004) and frequency of bathing/showering ≤ 1 
times per week (OR= 1.15; 95% CI = .65-2.10; p=.002) was significantly associated with DD.