Comparative Efficacy and Safety of Topical Tacrolimus vs. Mometasone in Pediatric Localized Vitiligo: A Retrospective Study

doi:10.21203/rs.3.rs-5235116/v1

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Method Article

Comparative Efficacy and Safety of Topical Tacrolimus vs. Mometasone in Pediatric Localized Vitiligo: A Retrospective Study

https://doi.org/10.21203/rs.3.rs-5235116/v1

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Background:
Mometasone furoate 0.1% cream and tacrolimus 0.03% cream are commonly used treatments for vitiligo, where achieving repigmentation and managing side effects are key outcomes. This study compares the efficacy and side effect profiles of these two treatments over 3 and 6 months using patients' medical records, as well as analyzing statistical significance through the Wilcoxon rank-sum (Mann-Whitney) test.

Objective:
The objective of this study is to compare the safety and efficacy of tacrolimus 0.03% ointment compared to mometasone furoate 0.1% cream in the treatment of vitiligo in children.

Methods:
For efficacy, repigmentation was categorized in ranges (1-24%, 25-49%, 50-74%, and 75-100%) and assessed at 3 and 6 months for both treatments to measure the efficacy. Adverse effects, such as atrophy, burning sensation, erythema, and pruritus, were assessed. The differences in efficacy and adverse effects were analyzed using a two-sample Wilcoxon rank-sum test.

Results:
Tacrolimus showed higher rates of repigmentation, with 40% of patients achieving 75-100% repigmentation at 3 months and 32% at 6 months, compared to mometasone which had the same repigmentation range in 34% of patients at 3 months and 23% at 6 months. However, the statistical analysis (p = 0.6170) indicated that there is no significant difference in the overall repigmentation efficacy between the treatments. In terms of adverse effects, tacrolimus had a slightly better safety profile, with fewer cases of atrophy and burning sensation, and a higher percentage of patients reporting no side effects. Nevertheless, no statistically significant difference was found (p = 0.6170).

Conclusion:
Both treatments were effective, but tacrolimus demonstrated a slightly better long-term repigmentation and fewer side effects, making it a favorable option for localized vitiligo in children. Although the side effect profiles were comparable, tacrolimus showed a marginally better tolerability. These findings suggest that treatment selection should consider patient-specific factors, such as skin sensitivity and lesion location, to optimize therapeutic outcomes.

Dermatology

Vitiligio

Tacrolimus topical

Mometasone

Vitiligo is generally a normal idiopathic, acquired depigmentation disorder of the skin and hair that influences approximately 0.5% of the global population¹. This chronic condition arises from the selective destruction of melanocytes, the cells responsible for skin pigmentation².³. Managing vitiligo represents a challenging issue since it has a profound impact on patients' confidence and social lives. Moreover, the complex pathophysiology and its unpredictable nature make it difficult to target therapies effectively. Vitiligo is considered the most commonly recognized depigmenting condition and can be divided into two main categories which are segmental and nonsegmental vitiligo⁵.

The largest epidemiological study on vitiligo was conducted in 1977 on the island of Bornholm, Denmark. In this study, vitiligo was reported to affect 0.38% of the population. The global prevalence of vitiligo is commonly cited as 0.5-1%, though precise prevalence rates are difficult to assess, with some studies reporting rates as high as 8.8% in India, followed by Mexico (2.6-4%) and Japan (1.68%). The variation in prevalence data may be due to differences in reporting, particularly in regions where social and cultural stigma around the condition is prevalent, leading patients to seek early medical attention, or where lesions are more visible on darker skin tones.⁶.

Although there is no cure for vitiligo, available treatments can alter the progression of the disease and induce varying levels of repigmentation, often with satisfactory restorative outcomes⁷. Common treatments include systemic glucocorticoids, which are the first-line therapy for disease stabilization, phototherapy which is recommended for both adults and children in whom fundamental corticosteroids are contraindicated, and topical treatments. Targeted UVB phototherapy or narrowband UVB (NBUVB) phototherapy can be used as monotherapy to stabilize active vitiligo. NBUVB treatment is administered several times per week and typically requires six months to one year to achieve optimal results for stabilization and repigmentation.

Topical treatments include topical corticosteroids and calcineurin inhibitors. Guidelines suggest that topical calcineurin inhibitors (TCIs)—including tacrolimus 0.03% and 0.1% ointment for adults, 0.03% for children aged ≥ 2 years^7.8, and pimecrolimus cream 1% for patients ≥ 2 years—as second-line options for short-term, intermittent treatment of vitiligo⁹.¹⁰.¹¹.

Combination therapies, including the use of steroids, phototherapy, and lasers alongside tacrolimus, may provide better outcomes than tacrolimus alone as a monotherapy¹⁰.¹³

Further research is encouraged to evaluate the effectiveness of tacrolimus either as a mono- or as an adjuvant therapy for vitiligo^12.13.

To the best of our knowledge, no data currently exist on the comparative safety and efficacy of topical tacrolimus versus mometasone cream in treating localized vitiligo in children within Hamad Medical Corporation (HMC), the primary healthcare provider for dermatological conditions, including vitiligo, in Qatar. This study aims to address this gap by exploring the outcomes of these treatments in pediatric patients.

Study design and setting

This study is a comparative retrospective analysis that includes all children diagnosed with localized vitiligo who were treated with either tacrolimus 0.03% or mometasone 0.1% cream. The study was conducted at Hamad Medical Corporation (HMC) across three hospitals which are: Al Khor, Al Wakra, and Rumaila hospitals. These hospitals were selected because they are multi-specialty hospitals with a total of 826 inpatient beds and have dermatology and Venereology departments ^14,16. The study included patients who met the inclusion criteria during the period of June 2016 to December 2021. After screening, eligible patients were divided into two groups: one group received tacrolimus 0.03% cream, while the other group was treated with mometasone 0.1% cream. Both groups were followed retrospectively on a monthly basis. Outcomes were assessed by recording any side effects experienced and evaluating improvements in repigmentation. Treatment success was defined as achieving at least 75% repigmentation, which was measured using the Vitiligo Area Scoring Index (VASI) or other suitable methods, with evaluations conducted every three months.

Ethics approval

This study was approved by the Medical Research Center of HMC (MRC-01-22-556). Given the retrospective nature of the study, informed consent from participants was not required.

The research was conducted in full compliance with the principles outlined in the “Declaration of Helsinki”, adhered to Good Clinical Practice (GCP), and was carried out in accordance with the laws and regulations established by the Ministry of Public Health in Qatar.

Population

This study included all pediatric patients diagnosed with localized vitiligo who were initiated on treatment with tacrolimus 0.03% or mometasone 0.1% cream between June 2016 and December 2021, as identified through hospital medical records.

Inclusion criteria

Patients eligible for inclusion in the study met the following criteria:

Pediatric patients aged between 2 and 16 years.
Diagnosed with vitiligo covering a maximum of 10% of the body surface area (BSA).
Had completed a minimum of two months without any oral corticosteroids or other forms of phototherapy or other vitiligo treatments prior to the study.
Had no contraindications for using tacrolimus cream or mometasone 0.1% cream.

Exclusion criteria

Based on the following criteria patients were excluded from the study:

Pregnancy or lactation
Presence of autoimmune diseases.
Diagnosis of another form of vitiligo.
Patients who did not attend at least one follow-up visit after the study initiation.
Patient with adrenal suppression ( Addison’s disease )

Sample size

Sample size calculation was not performed, as the objective was to include all patients meeting the inclusion criteria who were admitted to Al Khor Hospital (AKH), Al Wakra Hospital (WK), and Rumaila Hospital (RH) between June 1, 2016, and December 30, 2021.

statistical analysis

Statistical analyses were conducted to determine significant differences between the two groups: patients receiving mometasone 0.1% cream and those receiving tacrolimus 0.03% cream. Binary outcomes were analyzed with counts and percentages and compared using Two-sample Wilcoxon rank-sum (Mann–Whitney) test . Normally distributed continuous variables were analyzed as mean and standard deviation and compared using the Student t test. The Mann–Whitney test was used for results that remained non-normally distributed after log transformation. The study was conducted with 80% power, and a significant difference in one group was identified by analyzing the 95% confidence interval. All analyses were performed using StataNow 18.5 BE—Basic Edition, and data were collected with Microsoft Excel (Microsoft Corporation, Redmond, WA). Moreover, the study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist guidelines for reporting observational studies.

Table 1

Demographic characteristic of Patients Treated with Mometasone Furoate 0.1% Cream vs. Tacrolimus 0.03% Cream
Variables	Mometasone Furoate 0.1% Cream (N = 100)	Tacrolimus 0.03% Cream (N = 103)	Overall Mean / SD
Age (mean ± SD)	9.1 ± 3.72	7.1 ± 3.72	8.10 ± 3.72
Nationality, n (%)
Qatari	42 (42%)	46 (45%)
Non-Qatari	58 (58%)	56 (55%)
Sex, n (%)
Female	49 (49%)	49 (48%)
Male	51 (51%)	54 (52%)
BSA (mean ± SD)	1.09	0.90
Duration (mean)	6.7 months	5.3 months
Location of Vitiligo, n (%):
Face	41 (41%)	29 (28%)
Limbs	9 (9%)	7 (7%)
Hands	9 (9%)	8 (8%)
Genital Area	10 (10%)	7 (7%)
Eyelashes	8 (8%)	24 (23%)
Legs	12 (12%)	11 (11%)
Abdomen	4 (4%)	5 (5%)
Thorax	0 (0%)	0 (0%)
Buttocks	5 (5%)	5 (5%)
Axillae	0 (0%)	0 (0%)
Elbows	4 (4%)	5 (5%)

The demographic characteristics of patients treated with mometasone furoate 0.1% cream (N = 100) and tacrolimus 0.03% cream (N = 103) are summarized in Table 1. The mean age of patients in the mometasone group was slightly higher at 9.1 ± 3.72 years compared to 7.1 ± 3.72 years in the tacrolimus group, with an overall mean age of 8.10 ± 3.72 years across both groups. Nationality wise, patients distribution was comparable between two groups, with 42% Qatari in the mometasone group and 45% Qatari in the tacrolimus group. The remaining patients were non-Qatari, comprising 58% of the mometasone group and 55% of the tacrolimus group, which represents a relatively balanced representation of nationalities across treatments. The sex distribution was also similar between both groups, which suggests that the treatments were tested on relatively equivalent populations in terms of gender.

The mean BSA for patients using mometasone was 1.09, which is slightly higher than the 0.90 recorded for patients using tacrolimus. Additionally, the mean duration of vitiligo treatment was longer in the mometasone group at 6.7 months, compared to 5.3 months in the tacrolimus group.

The location of vitiligo lesions varied slightly between the two treatment groups. In the mometasone group, the most commonly affected areas were the face (41%) and legs (12%), while in the tacrolimus group, eyelashes (23%) were the most affected area, followed by the face (28%). The hands, genital area, and limbs were approximately similarly affected across both treatment groups. Notably, neither group had patients with vitiligo affecting the thorax or axillae, indicating these locations were less commonly impacted in this cohort. Overall, the two patient groups were comparable in terms of demographic characteristics, with only slight variations in age, BSA, and vitiligo lesion locations. These similarities provide a solid foundation for comparing the efficacy and safety of both treatments in terms of efficacy and safety.

Table 2

The efficacy comparison
Target lesion repigmentation from baseline %	mometasone furoate 0.1% cream Repigmentation (%)		tacrolimus 0.03% cream Repigmentation (%)
	3 months	6 months	3 months	6 months
1–24%	4	6	8	10
25–49%	3	25	1	21
50–74%	28	16	24	15
75–100%	34	23	40	32
no repigmentation	29	24	26	18
not specify	2	6	3	6

Based on the table above, mometasone furoate 0.1% demonstrated higher repigmentation levels (notably in the 50–74% and 75–100% categories) after 3 months. However, this effect plateaued or slightly decreased by 6 months, suggesting a reduction in efficacy over time. In contrast, tacrolimus 0.03% showed a more rapid response, with significant repigmentation in the 75–100% category at 3 months, which slightly decreased by 6 months but remained relatively high. Overall, both treatments effectively reduced the number of lesions with patients who reported no repigmentation over time, indicating overall efficacy in promoting repigmentation. Moreover, tacrolimus induced higher levels of repigmentation earlier (within the first 3 months) compared to mometasone, particularly in the higher repigmentation categories.

The treatment groups were compared at 3 and 6 months using the Two-sample Wilcoxon rank-sum (Mann-Whitney) test. At 3 months the resulting p-value was 0.6170, which is above the conventional alpha levels (0.05 or 0.01), indicating no statistically significant difference between the two treatments based on the rank-sum test. As a result, the null hypothesis cannot be rejected, suggesting that the efficacy of mometasone furoate 0.1% and tacrolimus 0.03% is comparable at 3 months. Similarly, at 6 months, the analysis revealed no significant differences between the treatments (p-value = 0.79). Tacrolimus showed approximately 70% of patients (n = 72) achieving full recovery (75–100% repigmentation) by 6 months, compared to 57% of patients (n = 57) in the mometasone group. While there was a trend toward higher repigmentation with tacrolimus at earlier time points, there is no strong evidence suggesting that one treatment is superior to the other in terms of repigmentation outcomes based on this analysis.

Table 3

Side effects associated with the use of mometasone furoate 0.1% cream and tacrolimus 0.03% cream in the treatment of Vitiligo
Side Effect	mometasone furoate 0.1% cream	tacrolimus 0.03% cream
Atrophy	4	2
Burning sensation at site of apply	22	10
Erythema	5	7
Pruritus	38	37
No side effect	31	47

The above table demonstrates the side effects associated with the use of mometasone furoate 0.1% cream and tacrolimus 0.03% cream. The most commonly reported side effect in both treatment groups was pruritus which was similar in both groups. For atrophy, mometasone may carry a higher risk since it was reported in 4 patients compared to 2 patients in the tacrolimus group. Additionally, patients using mometasone experienced more frequent burning sensations at the application site (22 cases) compared to those using tacrolimus (10 cases). This suggests that tacrolimus may provide more tolerable side effects for patients in terms of localized discomfort. A noteworthy finding is the higher rate of patients reporting no side effects in the tacrolimus group (47%) compared to the mometasone group (31%). This difference highlights a potentially better safety profile for tacrolimus, making it a preferable option for patients concerned about side effects.

Statistical analysis using the Wilcoxon rank-sum test indicated that there is no statistically significant difference in the overall side effect profiles between the two treatments. This result suggests that while tacrolimus may present a more favorable side effect profile, the differences observed do not reach conventional levels of statistical significance.

Although both treatments were found to be associated with common side effects, tacrolimus 0.03% cream appears to have a more favorable profile, with fewer instances of severe side effects such as atrophy and burning sensations. This finding suggests that tacrolimus may be better tolerated for long-term management of skin conditions, particularly in patients who are sensitive to the adverse effects associated with topical therapies.

This study compares the efficacy and safety profiles of mometasone furoate 0.1% cream and tacrolimus 0.03% cream over a 3- and 6-month period, in the treatment of vitiligo. Statistical analysis was performed using the Wilcoxon rank-sum (Mann-Whitney U) test to evaluate differences in the two treatment outcomes.

Repigmentation Efficacy

At 3 month duration of treatment, 34% of patients in the mometasone furoate group achieved 75–100% repigmentation, while 40% of patients in the tacrolimus group reached the same level. By 6 months, 32% of patients treated with tacrolimus showed 75–100% repigmentation, while the percentage in the mometasone group decreased to 23%. This suggests that tacrolimus may result in faster repigmentation than mometasone which shows a delayed but a progressive improvement ¹⁹. In contrast, multiple studies, including those by Grimes et al., have demonstrated superior long-term repigmentation with tacrolimus compared to corticosteroids, particularly in areas with thinner skin, such as the face and neck ²⁰. This might be due to its mechanism of action as a calcineurin inhibitor, which works by suppressing T-cell activity, preventing immune-mediated damage to melanocytes. These findings align with the current study, which shows better sustained repigmentation with tacrolimus.

Corticosteroids such as mometasone furoate are widely used in treating vitiligo due to their potent anti-inflammatory effects, promoting early repigmentation by suppressing the autoimmune response in active vitiligo lesions ¹⁷. However, tachyphylaxis, a reduced response to treatment over time, is a well-documented phenomenon with corticosteroids, limiting their long-term effectiveness. Moreover, studies have shown that while corticosteroids are effective in the short term, their long-term efficacy can decline if not combined with other therapies ¹⁸. Tacrolimus, a calcineurin inhibitor, works by suppressing T-cell activity, thus reducing immune-mediated damage to melanocytes. It has been shown to be particularly effective in areas with thinner skin (e.g., face and neck), and several studies have reported better long-term repigmentation with tacrolimus than corticosteroids ¹⁹. Grimes et al. found that tacrolimus not only promoted repigmentation in vitiligo but also sustained it for a longer duration compared to potent corticosteroids ²⁰. These findings align with the current study, which shows better sustained repigmentation with tacrolimus.

Side Effects

The side effect profiles of both treatments were also evaluated. The side effect profiles of both treatments were also evaluated. In the mometasone group, there were 4 cases of atrophy, 22 cases of burning sensation, and 38 cases of pruritus. On the other hand, the tacrolimus group experienced 2 cases of atrophy, 10 cases of burning sensation, and 37 cases of pruritus. 47% of tacrolimus patients reported no side effects, compared to 31% in the mometasone group.

Corticosteroids, including mometasone, are known to induce skin atrophy, particularly with long-term use or when applied to areas of thinner skin. This is primarily due to their inhibition of collagen synthesis, resulting in skin thinning and potential telangiectasia ²¹. Burning sensations and itching are common with corticosteroids, particularly when first applied to inflamed skin, as shown by studies where potent steroids led to adverse effects in over 20% of users ²².

Tacrolimus has a more favorable safety profile compared to corticosteroids, particularly in terms of avoiding skin atrophy, since it does not affect collagen synthesis. Studies, including Kim et al. (2006), have demonstrated that tacrolimus is safe for long-term use on sensitive areas such as the face, with minimal risk of systemic absorption or long-term side effects ²³. While some patients report a burning sensation upon initial application, this effect typically subsides after a few days. In clinical trials, up to 70% of patients using tacrolimus reported no significant side effects, reflecting the high tolerability observed in this study ²⁴.

The Mann-Whitney U test resulted in a p-value of 0.6170, indicating no statistically significant difference in the efficacy of repigmentation between mometasone furoate and tacrolimus over the course of treatment. Previous studies have shown varying results when comparing corticosteroids and tacrolimus. Some trials have reported that tacrolimus is more effective in the long-term management of vitiligo, especially in maintaining repigmentation ⁹. However, corticosteroids like mometasone can be highly effective in initiating repigmentation, particularly in early active vitiligo. Studies have shown that combination therapy—using a corticosteroid for initial rapid repigmentation followed by tacrolimus for maintenance—can yield superior long-term results ²⁶. This approach minimizes the long-term side effects of corticosteroids while leveraging the sustained immune suppression offered by tacrolimus.

Mometasone furoate could be favored for short-term aggressive intervention, especially in areas less prone to atrophy (e.g., extremities). Its potent anti-inflammatory properties can induce faster initial repigmentation, but long-term use may be limited by side effects.Tacrolimus offers a better long-term safety profile and sustained repigmentation, particularly in sensitive areas like the face and neck. It should be considered a first-line treatment for long-term management, especially where atrophy is a concern. The lack of statistical significance (p = 0.6170) between the two treatments supports a personalized approach to therapy, where the choice of treatment depends on the patient's skin type, lesion location, and tolerance for side effects.

Both mometasone furoate 0.1% cream and tacrolimus 0.03% cream are effective in promoting repigmentation in patients with conditions like vitiligo. While mometasone may induce faster repigmentation, tacrolimus provides sustained long-term effects with fewer side effects. The choice between these treatments should be guided by individual patient characteristics and the specific needs of the treatment area. Combination therapy is a promising strategy for maximizing the benefits of both treatments while minimizing risks.

TCS	Topical corticosteroid
VASI	Vitiligo Area Scoring Index
BSA	Body surface area
HMC	Hamad medical corporation
ADR	Adverse drug reaction
TCIs	Topical calcineurins inhibitors
PUVA	Psoralen plus ultraviolet A

Author contributions

Conceptualization: Mutwakil Elbidairi, Mohamed Allam,Sara Khalid

Data curation: Mutaz Salih , Fuad Thaher , Mai Abuazzab, Oussama Allouch, Kawthar A Elnabi , Eiman A. Fattah, Mutwakil Elbidairi

Formal analysis: Oussama Allouch, Kawthar A Elnabi, Mutwakil Elbidairi

Methodology: Mutaz Salih

Validation: Mutwakil Elbidairi, sherif Attia, Mohamed Allam

Writing – original draft: Mutwakil Elbidairi, Sara Khalid

Writing – review & editing: Mutwakil Elbidairi, Kawthar A Elnabi, Eiman A Fattah, Sara Khalid, Mohamed Allam

Acknowledgments :

The completion of this research paper would not have been possible without the support and guidance of Palli V Abdulrouf, Nicole Nakousi, and Gabriel Carrijo. Their dedication and overwhelming attitude towards helping us is responsible for completing our research paper. The encouragement and insightful feedback were instrumental in accomplishing this task.

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The authors declare no competing interests.

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Comparative Efficacy and Safety of Topical Tacrolimus vs. Mometasone in Pediatric Localized Vitiligo: A Retrospective Study

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Abstract

Introduction

Method

Results

Discussion

Repigmentation Efficacy

Side Effects

Conclusion

Abbreviations

Declarations

References

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