|Year : 2020 | Volume
| Issue : 4 | Page : 283-286
Efficacy of fluticasone propionate ointment 0.005% in childhood lichen planus
Abhinav Kumar, Vibhu Mendiratta, Sarita Sanke, Ram Chander
Department of Dermatology and STD, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India
|Date of Submission||10-Jan-2019|
|Date of Decision||13-Mar-2019|
|Date of Acceptance||26-Apr-2020|
|Date of Web Publication||30-Sep-2020|
Dr. Sarita Sanke
Department of Dermatology and STD, Lady Hardinge Medical College and Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi - 110 001
Source of Support: None, Conflict of Interest: None
Background: Treatment of childhood lichen planus (LP) is challenging owing to high rate of relapses. Moreover, majority of treatment options for LP have been extrapolated from studies done in adults. Topical corticosteroid remains the first line of treatment in localized classic form of LP, but till date, no consensus exists regarding standardized therapy in children. Hence, we conducted this study to evaluate the efficacy of mid-potent topical steroid fluticasone propionate 0.005% in childhood LP. Aims and Objectives: The aim of this study was to evaluate the therapeutic efficacy of fluticasone propionate ointment 0.005% in childhood LP. Materials and Methods: Thirty-one patients (6 months to 18 years of age) with clinical and histopathologically confirmed diagnosis of LP were subjected to routine baseline severity assessment, patient/parent assessment, pretreatment photographic record of the fixed anatomical site under treatment, and then received topical mid-potent steroid therapy (fluticasone propionate ointment 0.005%) twice daily and cetirizine dihydrochloride in predefined doses for 8 weeks. Follow-up was done at the end of 2 weeks, 4 weeks, 6 weeks, and 8 weeks. After 8 weeks, a proportion of patients achieving clinical improvement and side effects were assessed. Observation and Results: The difference between pre- and posttreatment induration was not statistically significant (P = 0.336). The mean number of lesions before the start of treatment was 50.29, which reduced to 14.77 (P = 0.000) after treatment, and the mean of patients' itching score before treatment was 6.74 ± 1.6, which reduced to 2.61 ± 2.3 (P = 0.000) following treatment, which was statistically significant. Clinical improvement was seen in 67.7%, whereas 32.3% showed no improvement over a period of 8 weeks. Conclusion: Mid-potency steroid fluticasone propionate ointment twice daily is an effective therapeutic agent for localized childhood LP, with minimal side effects.
Keywords: Autoimmune, childhood lichen planus, fluticasone propionate, papulosquamous
|How to cite this article:|
Kumar A, Mendiratta V, Sanke S, Chander R. Efficacy of fluticasone propionate ointment 0.005% in childhood lichen planus. Indian J Paediatr Dermatol 2020;21:283-6
|How to cite this URL:|
Kumar A, Mendiratta V, Sanke S, Chander R. Efficacy of fluticasone propionate ointment 0.005% in childhood lichen planus. Indian J Paediatr Dermatol [serial online] 2020 [cited 2020 Oct 29];21:283-6. Available from: https://www.ijpd.in/text.asp?2020/21/4/283/296849
| Introduction|| |
Lichen planus (LP), a papulosquamous disease of unknown etiology, is considered to be an autoimmune T-cell-mediated disease that affects the skin, mucous membrane, hair follicles, and nail. Several morphological variants are known: hypertrophic, atrophic, erosive, ulcerative, follicular, annular, linear, vesicular, bullous, actinic, LP pigmentosus, and LP pemphigoides.
LP in childhood is common in subtropical countries such as India. Childhood LP cases are typically sporadic, however, 1%–2% can be familial. It occurs with equal frequency in both genders. Treatment of LP in children is often unsatisfactory owing to high failure rate and frequent relapses. There is no standard treatment available for LP and several agents such as topical and systemic corticosteroids, retinoids, azathioprine, griseofulvin, dapsone, cyclosporine, methotrexate, cyclophosphamide, hydroxychloroquine, and tacrolimus have been employed in the past. Treatment of childhood LP is further challenging as majority of treatment options have been extrapolated from experience in adults. Corticosteroids and antihistamines remain the mainstay of treatment, topical steroids for localized LP, and systemic corticosteroids for generalized cases.
Hence, we conducted this study to evaluate the efficacy of mid-potent topical steroid fluticasone propionate 0.005% on various clinical features of childhood LP such as induration of the lesions, pruritus, and lesional count and also to assess the side effects of the steroid.
Aims and objectives
Our aim was to evaluate the therapeutic efficacy of fluticasone propionate ointment 0.005% in childhood LP.
Mid-potent steroids are known to be efficacious in childhood LP. Fluticasone propionate 0.005% ointment is a mid-potent steroid and is a safer option for use in children. Hence, this was used. Our objectives were to assess the proportion of patients achieving clinical improvement in disease severity, the time taken for clinical improvement, and the side effect profile of fluticasone propionate in these patients.
| Materials and Methods|| |
It was an observational study conducted in the department of dermatology of a tertiary care hospital. The study was approved by the ethics committee. Informed written consent was obtained from all participants for their participation in the study as well as to use their data. The inclusion criteria included all patients (6 months to 18 years of age) with clinical and histopathologically confirmed diagnosis of LP and giving consent for the study. The exclusion criteria included:
- Patients who had received phototherapy in the past 3 months
- Patients on treatment with topical/systemic steroids/any other treatment in the past 1 month
- Morphological variants such as atrophic, actinic, follicular LP, mucosal LP, genital LP, bullous LP, and LP pigmentosus
- LP involving >20% body surface area
- Renal or liver impairment in patients.
Detailed clinical history was taken and examination was done of all the patients recruited for the study. Children were subjected to routine baseline severity assessment by an independent observer in the department of dermatology, patient/parent assessment using a patient/parent score [Table 1], and pretreatment photographic record of the fixed anatomical site under treatment.
The recruited patients were advised topical mid-potent steroid therapy (fluticasone propionate ointment 0.005%) twice daily and cetirizine dihydrochloride in predefined doses for 8 weeks.
“Fingertip unit” was used for the assessment of quantity to reduce the variation in the use of topical corticosteroid (TC) and to encourage adherence to therapy. A patient was advised to apply the drug after bath without topical occlusion twice daily.
Cetirizine was given in the following doses:
- 6 months to 5 years: 2.5 mg orally once a day
- 6 years or older: 10 mg orally once a day.
An arbitrary nonstandardized severity score for LP was used to assess the patient which included the observer assessment for induration of the lesions and patient/parent assessment for severity of itching and flattening of lesions, as given in [Table 1]. Both these assessments were done on day 0 and at the end of the 2nd week, 4th week, 6th week, and 8th week from the day of enrollment in the treatment group. The lesions were assessed by an observer, and the same observer provided the treatment. Blinding was not used. For children <10 years, the intensity of pruritus was measured by parents/guardians by noting the frequency of disturbance in sleep and intensity of scratching throughout the day.
Number of lesions: The total number of lesions was counted on day 0 and at the end of the 2nd week, 4th week, 6th week, and 8th week.
Clinical improvement was defined as fulfillment of at least two out of these three criteria:
- At least 1-grade improvement in induration of the lesion
- At least 50% reduction in number of lesions
- Improvement in patient/parent assessment of severity by at least 3 points in the subjective scale.
Clinical photograph – Representative fixed anatomical site was photographed in each patient on the 0th day and at the end of the 6th week and 8th week of enrollment in the treatment group using a DSC-W170 Sony Cyber-shot digital camera.
Any adverse effects of topical steroid such as hypopigmentation (perilesional), atrophy, telangiectasia, furunculosis, hypertrichosis, acneiform eruptions, pruritus, or any other effect reported by the patient were noted and dealt with accordingly.
The data were analyzed using SPSS (version 18.0 IBM corp., Chicago, USA) using appropriate tests. Categorical variables are expressed as frequencies and percentages and analyzed using the Chi-square test considering P < 0.05 as statistically significant. Quantitative variables are presented as mean ± standard deviation. Statistical significance was tested by t-test and Chi-square test.
| Observations and Results|| |
A total of 42 patients were enrolled in the study. Ten patients were excluded based on the exclusion criteria, and 1 patient lost to follow-up. A total of 31 patients completed the study. The age of our patients ranged from 2 to 18 years, with a mean of 11.61 ± 5.1 years. The mean duration of disease was 8.63 ± 9.4 months. Eighteen (58%) were females, whereas 13 (41%) were males.
The characteristics of the patients are given in [Table 2]. Moderate induration was present in 11 (35.5%) patients before the start of treatment, whereas the rest, that is, 20 (64.5%) patients, had severe induration. Following treatment, the number of patients with moderate and severe induration reduced to 9 (29%) and 5 (16.1%), respectively. Fifteen (48.4%) patients had mild induration, whereas 2 (6.5%) had no induration following treatment. The difference between pre- and posttreatment induration severity was not statistically significant (P = 0.336).
The mean number of lesions before the start of treatment was 50.29, which reduced to 14.77 posttreatment (P = 0.000). The mean of patients' itching score before treatment was 6.74 ± 1.6, which reduced to 2.61 ± 2.3 (P = 0.000) following treatment, as shown in [Table 2]. The most common side effect of topical fluticasone propionate 0.005% was atrophy noted in 7 (22.6%) patients, followed by hypopigmentation in 2 (6.5%) patients. These side effects were seen after 6 weeks of treatment in 3 (9.7%) patients and after 8 weeks in 5 (16.1%) patients.
Clinical improvement according to the defined criteria was seen in 21 (67.7%) patients, whereas 10 (32.3%) patients failed to respond to the treatment [Figure 1]a, [Figure 1]b and [Figure 2]a, [Figure 2]b. The earliest clinical improvement was observed at 2 weeks in 1 (3.2%) patient and at 4 weeks in 4 (12.9%) patients. Majority of the patients, that is, 14 (45.2%) patients, showed clinical improvement at 6 weeks. Two children (6.5%) exhibited a late clinical response to treatment at 8 weeks.
|Figure 1: (a) Lichen planus lesions over the leg (at week 0). (b) Marked improvement, posttreatment (week 6)|
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|Figure 2: (a) Localized lichen planus (week 0). (b) Mild Improvement, posttreatment (week 6)|
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| Discussion|| |
TC forms the first line of treatment in localized classic form of LP, but till date, no consensus exists regarding standardized therapy regimens for LP in childhood. We could not find any clinical trial specifically dedicated to the treatment of cutaneous LP with TC.
An arbitrary, nonstandardized method to assess the treatment response to fluticasone propionate ointment (0.005%) and cetirizine in syrup or oral form was devised which included scoring the induration, counting of number of lesions, and itching score of the patient. A self-designed criterion based on symptoms and clinical improvement in morphology was made, and patients were assessed on the basis of the same.
The youngest patient in our study was 2 years. The earliest reported age was 2 weeks in a previous study. The mean age of our study population was 11.61 ± 5.0 years, whereas the mean age in larger studies has been 7.1–8.4 years., The male-to-female ratio was 1:1.6, which shows a higher female preponderance.
The mean “clinical improvement” was seen in 67.7%, whereas 32.3% had no clinical improvement over a period of 8 weeks. One large Indian study in children showed a clinical response of 28.8% over a period of 14 months. The maximum number of patients (45.2%) showed “clinical improvement” at week 6 from the start of treatment, whereas the earliest “clinical improvement” was seen at 2 weeks. A significant response to topical steroids (moderate-to-high potency) alone was seen in 16 patients of childhood LP in a study conducted by Nanda et al.
Topical steroids constitute the mainstay of the treatment for cutaneous LP. Literature search shows the use of mid- and superpotent corticosteroids for the treatment of cutaneous LP in adults. There is a complete lack of published study that describes the use of TC formulation in different strengths in pediatric patients with LP. We found that fluticasone propionate 0.005% ointment used twice daily for 8 weeks was effective for localized cutaneous LP. Fluticasone propionate ointment has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Side effects were few and limited to atrophy and hypopigmentation in few lesions. Mild atrophy was noted in 22.6% of the cases which occurred over few lesions, along with hypopigmentation in few other cases. Thus, fluticasone propionate ointment 0.005% is a safe and effective drug for cutaneous LP in children with a faster response.
| Conclusion|| |
Mid-potency steroid fluticasone propionate ointment 0.005% twice daily significantly decreases the itching and the number of lesions and can be used as an effective treatment agent in childhood LP. The side effects associated with fluticasone propionate are few, limited to atrophy and hypopigmentation.
There were few limitations in our study which were small sample size, no long term follow-up, and no well-designed scoring system for evaluation of the severity of LP in children.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]