Journal of Pakistan Association of Dermatologists. 2014;24 (1):57-62.

Original Article
Comparative efficacy of topical mometasone
furoate 0.1% cream vs topical tacrolimus 0.03%
ointment in the treatment of atopic dermatitis
Md Alauddin Khan*, Lubna Khondker**, Dilshad Afroze*

*Department of Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka,

Bangladesh
**Department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical
University (BSMMU), Dhaka, Bangladesh

Abstract Objective To compare the efficacy of mometasone furoate and tacrolimus in the treatment of
atopic dermatitis.

Methods Sixty patients of atopic dermatitis were treated with mometasone furoate 0.1% (n=30)
and tacrolimus 0.03% (n=30). Both treatments were applied twice daily for 12 weeks. Patients
were followed up monthly. The disease severity assessed by SCORAD index. A 4-point scale
was used to measure the level of response to treatment.

Results Before treatment the respective mean SCORAD was 30.57±13.62 and 30.90±17.17 in
group A and B and at the end of treatment decreased to 11.87±12.04 and 11.20±13.85,
respectively (p>0.05). Percent reduction of severity from baseline to final follow-up was
69.20±23.41 in group A and 74.77±23.30 in group B (p=0.360). At final follow-up 56.7% of
group A and 63.3% of group B achieved excellent response, 13.3% of group A and 16.7% of
group B achieved good response.

Conclusion We conclude that both treatments, mometasone furoate and tacrolimus, are effective
in the treatment of atopic dermatitis.

Key words
Efficacy, mometasone furoate, tacrolimus, atopic dermatitis.

Introduction personal or family history of atopic dermatitis,

allergic rhinitis or asthma.3,4 In AD there is
Atopic dermatitis (AD) is an itchy, chronic or activation of the T helper 2 (Th2) immune
chronically relapsing, inflammatory skin response, with synthesis of cytokines IL-4, IL-
condition. The lesion is characterized by itchy 5, IL-10 and IL-13 and inhibition of T helper 1
papules, occasionally vesicles which become (Th1) response. IL-4 and IL-5 produces
excoriated and lichenified.1,2 Atopy is a elevated IgE level and eosinophilia in tissue
syndrome which may be defined as a and peripheral blood.5,6 Pruritus is the hallmark
genetically determined immune system of atopic dermatitis in all stages. 60% infantile
maturation disorder of unknown origin, in AD patients present in first year of life.7,8
which there is increased liability to form IgE Pruritus is paroxysmal and a constant feature.
antibodies and is frequently associated with Skin biopsy for histopathology show
spongiosis and edema of the epidermis,
Address for correspondence
Dr. Lubna Khondker, Assistant Professor, hyperkeratosis and acanthosis in chronic stage
Department of Dermatology and Venereology along with perivascular infiltrate of in upper
Bangabandhu Sheikh Mujib Medical University dermis.9,10 Topical corticosteroids are very
(BSMMU)
Dhaka, Bangladesh effective in atopic dermatitis but their frequent
Email: [email protected] and long-term use, particularly in children

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Journal of Pakistan Association of Dermatologists. 2014;24 (1):57-62.

have many side effects.11 Mometasone furoate medical treatment within 5 days before the
is a medium potency corticosteroid, indicated start of the study, pregnancy and lactation.
for the relief of the inflammatory and pruritic
manifestations of atopic dermatitis.12 Topical Procedure of data collection
calcineurin inhibitors like tacrolimus may be
used as alternate to steroid. Topical tacrolimus A total number of 60 patients were primarily
suppresses inflammation in a similar way to selected and they were randomized using
steroids and is equally as effective as a computer-generated codes into two groups
medium potency steroid.10 It does not cause (group A and group B), each of which
skin thinning or other steroid related side- included 30 patients. Complete history,
effects.13 To the best of my knowledge, no general physical and dermatological
study exploring the efficacy and safety of examinations were done for all enrolled
topical mometasone furoate comparing with patients. History and physical findings were
topical tacrolimus in the treatment of atopic recorded in a structured proforma. Patients,
dermatitis has yet been conducted in who matched the inclusion and exclusion
Bangladesh. So, to know and to treat the criteria and freely gave their informed consent,
patient with atopic dermatitis in an effective were selected for the study.
way, such kind of study was conducted in
Bangladesh. Intervention

Methods Group A was treated with mometasone furoate

0.1% ointment and group B with tacrolimus
A clinical trial was conducted in department of 0.03% ointment. Both preparations were
Dermatology and Venereology, Bangabandhu applied twice daily for a period of 12 weeks.
Sheikh Mujib Medical University, Dhaka. The Patients were clinically assessed monthly for
duration of the study was from September three months. Each time the severity of the
2011 to February 2012. Patients of atopic disease was recorded and clinical photographs
dermatitis attending outpatient department of were taken. The severity of disease was
Dermatology and Venereology, Bangabandhu measured by Scoring of Atopic Dermatitis
Sheikh Mujib Medical University, Dhaka were (SCORAD) index. For calculating SCORAD
the study population. Purposive type of non- index, six clinical signs were recorded for each
probability sampling method was followed in case: erythema, edema/papulation,
this study. Inclusion criteria were patients of oozing/crusting, excoriations, lichenification
atopic dermatitis diagnosed clinically, patient and dryness. Disease extent was measured by
who gave informed written consent, age more using the rule of nine. The average intensity of
than 2 years and patients of either gender. each clinical sign was graded from 0 to 3
Exclusion criteria were: known (0=absent, 1=mild, 2=moderate, and 3=severe)
hypersensitivity to mometasone or tacrolimus, at a representative body site, per the SCORAD
patients suffering from hepatic, renal, protocol. Subjective symptoms, pruritus and
cardiovascular and hematological diseases, sleep loss were evaluated with regard to the
patients with co-existing acute infections, last 3 days and nights, and all were scored by
neoplasia, uncontrolled hypertension and the patients. Both subjective items were
diabetes mellitus, patients suffering from any graded on a 10-cm visual analogue scale. The
food allergy and other skin morbidity causing SCORAD index formula is: A/5 + 7B/2 + C.
acute onset of skin rash, skin disorders likely In this formula A is defined as the extent (0–
to affect drug absorption or disorders requiring 100), B is defined as the intensity (0-18) and C

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Journal of Pakistan Association of Dermatologists. 2014;24 (1):57-62.

is defined as the subjective symptoms (0-20). Table 1 Demographic and clinical data of patients.
The maximum SCORAD score is 103 (i.e. Group A Group B
(n=30) (n=30)
patients with high score are rated “worse"). Age (years)
2 to10 15 (50.0)# 20 (58.3)*
A 4-point scale was used to measure the level >10 15 (50.0) 10 (33.3)*
Mean ± SD 21.73±4.30 19.70±3.44*
of response to treatment, if >75% clear -
Age at onset 9.37±4.07 7.42±3.12*
excellent response; if 50-75% clear - good Duration of
16.60±17.21 28.20±38.71*
response; if 25-50% clear fair response; if disease (mo)
Erythema 30 (100.0) 30 (100.0)*
<25% clear - poor response.
Papules 30 (100.0) 30 (100.0)*
Excoriation 5 (16.7) 5 (16.7)*
Data analysis Affected sites
Extremities 29 (96.7) 30 (100.0)*
Trunk 2 (6.7) 2 (6.7)*
Data analysis was performed by Statistical Face 1(3.3) 1 (3.3)*
Package for Social Science (SPSS), version- * p>0.05, Unpaired t test.
12. Level of significance (p value) was set at
Table 2 Extent of score of erythematous lesion,
0.05 and confidence interval at 95%.
papules and excoriation in different follow-up.
Group A Group B
Results Erythematous lesion
Baseline 12.77±4.01 11.80 ±3.93
Table 1 shows the clinical characteristics in 1st follow-up 7.80±4.11 7.77 ±4.08
2nd follow-up 6.10±4.03 5.63 ±4.16
the two groups. Both groups were comparable
Final follow-up 4.17±4.02 3.47 ±4.00
in all parameters (p<0.05). Mean age of group Papules
A patients was 21.73±4.30 and group B was Baseline 17.30±10.29 18.57±13.88
1st follow-up 12.40±9.46 13.10± 12.67
19.70±3.44 years. 50% of group A and 58.3%
2nd follow-up 9.97±8.73 10.10± 11.17
of group B were from the 2 to10 year age Final follow-up 7.63±8.08 7.73±9.98
group and 50.0% of group A and 33.3% of Excoriation
Baseline 0.50±1.33 0.53±1.28
group B wee older than 10 years. Mean age of
1st follow-up 0.30±0.88 0.30±0.75
onset of disease was 9.37±4.07 years and 2nd follow-up 0.17±0.59 0.10±0.31
7.42±3.12 years in group A and group B, Final follow-up 0.07±0.37 0.00
respectively (p=0.420). Mean duration of *p>0.05, Unpaired t test.
disease was 16.60±17.21 months and Table 3 SCORAD (Mean of total scoring of Atopic
28.20±38.71 months in group A and group B, dermatitis) in different follow up.
respectively (p=0.139). Group A Group B
Baseline 30.57±13.62 30.90±17.17*
1st follow-up 20.50±13.64 21.17±16.94*
All patients of both groups presented with 2nd follow-up 16.23±12.74 15.83±15.29*
erythema, papules and 16.7% presented with Final follow-up 11.87±12.04 11.20±13.85*
excoriation (p=0.999). Lesions on extremities % reduction from
baseline to final 69.20±23.41 74.77±23.30*
were present in 96.7% of group A and 100.0% follow-up
of group B, lesions on trunk were present in *p>0.05, Unpaired t test.
6.7% and lesions on face in 3.3% (p>0.05).
was 12.77±4.01 and 11.80±3.93, respectively
In Table 2 effect of both treatments on three (p=0.350). At 1st follow-up mean number of
cardinal signs of diseases is compared. Both erythematous lesions in group A and group B
groups showed a comparable improvement was 7.80±4.11 and 7.77±4.08, respectively, at
(p>0.05). At baseline, mean number of 2nd follow-up it was 6.10±4.03 and 5.63±4.16
erythematous lesions in group A and group B and at final follow-up 4.17±4.02 and

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Journal of Pakistan Association of Dermatologists. 2014;24 (1):57-62.

Table 4 Clearance level of disease at different At 1st follow up 3.3% of both group got
follow-ups. excellent response, 10.0% of group A and
Group A Group B
1st follow up 26.7% group B got good response, 60.0% of
Excellent 1 (3.3)# 1 (3.3) group A and 40.0% of group B got fair
Good 3 (10.0) 8 (26.7) response and 26.7% of group A and 30.0% of
Fair 18 (60.0) 12 (40.0)
Poor 8 (26.7) 9 (30.0) group B got poor response (p=0.317).
2nd follow up
Excellent 4 (13.3) 9 (30.0) At 2nd follow up 13.3% of group A and 30.0%
Good 14 (46.7) 12 (40.0)
of group B got excellent response, 46.7% of
Fair 9 (30.0) 7 (13.3)
Poor 3 (10.0) 2 (6.7) group A and 40.0% of group B got good
3rd follow up response, 30.0% of group A and 13.3% of
Excellent 17 (56.7) 19 (63.3) group B got fair response and 10.0% of group
Good 4 (13.3) 5 (16.7)
Fair 7 (23.3) 5 (16.7) A and 6.7% of group B got poor response
Poor 2 (6.7) 1 (3.3) (p=0.470). At final follow up 56.7% of group
*p>0.05, Chi square test. A and 63.3% of group B achieved excellent
response, 13.3% of group A and 16.7% of
3.47±4.00 (p>0.05). At baseline mean number
group B achieved good response, 23.3% of
of papules in group A and group B was
group A and 16.7% of group B achieved fair
17.30±10.29 and 18.57±13.88, respectively
response and 6.7% of group A and 3.3% of
(p=0. 690). At 1st follow-up, mean number of
group B achieved poor response (p=0.828).
papules in group A and group B was
12.40±9.46 and 13.10±12.67, respectively. At
Discussion
2nd follow up, it was 9.97±8.73and
10.10±11.17 and at final follow-up 7.63±8.08 In our study, both treatments showed a
and 7.73±9.98 (p>0.05). At baseline, mean significant improvement in mean scores of
number of excoriation in group A and group B three important clinical signs of AD, mean
was 0.50±1.33 and 0.53±1.28, respectively SCORAD index and level of clearance in their
(p=0. 922). At 1st follow up mean number of respective groups (p<0.05). The improvement
excoriation in group A and group B was in all these parameters was similar in two
0.30±0.88 and 0.30 ± 0.75 respectively, at 2nd groups (p>0.05), showing that both drugs are
follow up it was 0.17±0.59 and 0.10±0.31 and equally effective in children as well adults
at final follow up 0.07±0.37 and 0.00 suffering from AD. The efficacy of both drugs
(p>0.05). is proven in children9,10 but few studies14
directly compared these two drugs in AD.
At baseline mean of total score of atopic
dermatitis was 30.57±13.62 and 30.90±17.17 Gradman et al.14 compared the suppressive
in group A and B, at 1st follow up it was effects of topical mometasone furoate and
20.50±13.64 and 21.17±16.94, respectively in tacrolimus on skin prick testing in 12 children
group A and B, at 2nd follow up it was with atopic eczema before and after 2 weeks of
16.23±12.74 and 15.83±15.29 and at final treatment with topical mometasone furoate and
follow up it was 11.87±12.04 and 11.20±13.85 tacrolimus. Both treatments significantly
respectively in group A and B (p>0.05). suppressed the allergen wheal size.
Percent reduction of severity from base line to
final follow up was 69.20±23.41 in group A Pei et al.15 conducted a study to observe the
and 74.77±23.30 in group B (p=0.360). effectiveness of wet wrap dressings using
0.1% mometasone furoate and 0.005%

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Journal of Pakistan Association of Dermatologists. 2014;24 (1):57-62.

fluticasone proprionate ointments in the tacrolimus in the treatment of atopic

treatment of moderate to severe atopic dermatitis.
dermatitis in children. There was significant
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