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Original Article
Vol (II) No (II) July-December 2013
Clinical Study of Efficacy of Topical Tacrolimus in Various Dermatoses
Jigna Padhiyar*, Krina B. Patel**, Nayan Patel***, Kishan Ninama****, Yogesh B. Shah*****
Abstract :
Introduction : Tacrolimus is a calcineurin inhibitor. Topical tacrolimus (0.03% and 0.1%) is currently approved for the
treatment of atopic dermatitis. It has been found to be an effective treatment for oral erosive lichen planus, cutaneous
lichen planus, psoriasis, vitiligo, few bullous and many other inflammatory dermatoses. Material and methods : Total
140 patients with clinically diagnosed dermatological conditions thought to be amenable to topical tacrolimus ointment
attending our department were included in this study. Almost all children (except few who were given 0.1%) were given
0.03% topical tacrolimus. 0.03% topical tacrolimus was given on all mucosal lesions. Adults with skin lesions were either
given 0.03 or 0.1% as per requirement. Results : Topical tacrolimus is very effective in treating atopic dermatitis, oral
erosive lichen planus, vitiligo, genital lichen sclerosusatrophicus and post herpes labialis depigmentation. Its efficacy in
other dermatoses like – granuloma annulare, twenty nail dystrophy, alopecia areata, hand eczema etc. - needs larger study
to prove its usefulness as steroid sparing agent.
Key Words: efficacy, topical tacrolimus, various dermatoses
Introduction :
any component of ointment, children < 2 yr, active skininfection at the site to be treated, netherton syndrome The macrolide immunomodulators in clinical use are- aims of to assess the efficacy of topical tacrolimus in various cyclosporine and sirolimus (rapamycin) .
dermatoses and to assess the adverse effect profile of the tacrolimus - a calcineurin inhibitor produced by the soil bacterium stretomycestsukubaensis was isolated in year1984, has strong immunosuppressive activity in vivo and Material and methods :
prevents the activation of t-lymphocytes in response to Patients with clinically diagnosed dermatological conditions thought to be amenable to topical tacrolimus tacrolimus is derived by taking the ‘t' for tsukuba, the name ointment attending a tertiary teaching institute were of mountain where the soil sample was extracted, ‘acrol' included in this study. Biopsy was taken when necessary.
for macrolide and ‘imus' for immunosuppressant .
140 patients were included in the study after counselling for Topical tacrolimus (0.03% and 0.1%) is currently the compliance and side effect profile. Patients with approved for the treatment of atopic dermatitis (>2year of different dermatological disorders e.g. atopic dermatitis, age). (1, 4) FDA has approved topical tacrolimus for vitiligo, oral and genital erosive lichen planus, granuloma continuous use of one year. Topical therapy with annulare, genital lichen sclerosusatrophicus, alopecia tacrolimus is safe and effective in paediatric and adult areata, cicatricial alopecia, chronic eczema, hand eczema, patient up to 4 years of continuous use. (5, 6) It has been post herpetic depigmentation, twenty nail dystrophy were found to be an effective treatment for oral erosive lichen included in the study. Pregnant and lactating women were planus, cutaneous lichen planus, psoriasis, vitiligo, few excluded in the study. 41 patients were lost to follow up bullous and many other inflammatory dermatoses. These after 1st visit and were not included in the result.
extensive arrays of disorders treated successfully with The details of history and examination findings were topical tacrolimus warrants further study of this drug.
recorded. A detailed lesion assessment including number of Contraindications include hypersensitivity to tacrolimus or lesions (where necessary), sites of the lesions, size of the lesions were carried out at visit-1(baseline), visit -2(15 days), visit-3(30 days), visit-4(60 days), visit-5(90 days), visit- ***** Professor, Skin Department, GCS Medical College, 6(120 days) and visit-7(150days). Photographs were taken Hospital & Research Centre, Ahmedabad, Gujarat, India at each visit.All patients were observed for the recurrence Associate Professor, Skin Department,GMERS Medical College-Sola, Gujarat, India of the lesion or any other unusual local skin reaction after Assistant Professor, Skin Department, SBKS Medical College the last visit for 7 months. Almost all children (except few and Research Centre, Vaghodia, Gujarat, India who were given 0.1%) were given 0.03% topical tacrolimus. 0.03% topical tacrolimus was given on all Padhiyar J et al: Topical Tacrolimus
mucosal lesions. Adults with skin lesions were either given0.03 or 0.1% as per requirement. Response to treatmentwas graded as - no improvement (<25% improvement),mild improvement (25%-50% improvement), moderateimprovement (50%-75% improvement), excellentimprovement (75%-90% improvement), completeimprovement (90%-100% improvement). Adversereactions were graded as mild- did not significantlyinterfere with patient's functioning, moderate - interfere Figure-3 : Oral erosive LP-
slightly with patient functioning and severe - interfere (A) before treatment (B) after treatment-
significantly with patient functioning.
excellent response
Results :
Out of 140 patients 41 patients were lost to follow up. Sototal 99 (male-39 and female-60) were included in thestudy for results.
In atopic dermatitis group (n=19), 9(47.37%) showedexcellent and 10(52.63%) showed complete response.
(Figure-1, 2) Figure-4: Alopecia areata-
In oral LP (lichen planus) group (n=21), 1(4.76%) showed (A) before treatment (B) after treatment-
no response, 2(9.52%) showed mild response, 7(33.33%) complete response
showed moderate response, 11(52.38%) showedexcellent response (figure-3) and complete response wasnot seen in any patient.
In alopecia areata group (n=4) 1(25%) showed completeresponse 3(75%) (figure-4) showed mild response.
Figure-5: Post-herpes labialis depigmentation-
(A) before treatment (B) after treatment-
complete response followed by new lesions.
Figure-1: Atopic dermatitis in child-
(A) before treatment (B) after treatment-
complete response
Figure-6: Pompholyx-
(A) before treatment (B) after treatment-
complete response.
Figure-2: Atopic dermatitis in adult-
In twenty nail dystrophy (n=2) both showed noimprovement. None of the patient of GA (granuloma (A) before treatment (B) after treatment-
annulare) group (n=2) showed response in this study during excellent response
Vol (II) No (II) July-December 2013
study period. In genital lichen sclerosus atrophicus (LSA) topical tacrolimus (n=27), 4(14.81%) showed no, group (n=3), 2(66.66%) showed moderate and 1(33.33%) 8(29.62%) showed mild, 5(18.51%) showed moderate, showed excellent response. In post herpes labialis 5(18.51%) showed excellent and 5(18.51%) showed depigmentation group (n=3), 1(33.33%) showed mild, complete response. In vitiligo group who did not showed 1(33.33%) showed excellent and 1(33.33%) showed any response to topical tacrolimus alone were additionally given topical steroids after study period (n=6), 1(16.66%) eczema group (n=3) 1(33.33%) showed complete showed no, 3(50%) showed mild and b2(33.33%) showed response (figure-6) and 2(66.66%) showed moderate response. In eczema other than hand eczema group (n=2) Only 4 (3.74%) out of total 99 patients reported mild transient adverse events. In scarring alopecia group (n=7), In scaring alopecia group (n=7) no showed improvement, 2(28.57%) showed adverse effect- one patient showed mild but one patient was having associated depigmentation and itching and other one showed pyoderma. In lichen depigmentation improved moderately but not scarring sclerosus atrophicus group (n=3), 1(33.33%) showed mild alopecia. In vitiligo group (n=33) who were only given erythema. In vitiligo group (n=33), 1(3.03%) showedacneform eruption.
Table 1: Efficacy and Safety Analysis for various Dermatoses
Table 2 : Efficacy and Safety Analysis for various Dermatoses (continued.)
Padhiyar J et al: Topical Tacrolimus
Discussion :
having scarring alopecia due to DLE but did not improve Hanifin JM et al (7) showed that there is >90% with 0.1% at 5 month. This again can be due to once/d improvement in 36.8 %( 0.1% ointment) and in 27.5 %( application of medicine and shorter duration of treatment.
0.03% ointment) with twice/day application for atopicdermatitis patients. My study showed >75% improvement References :
in all patient. So, once/day application may be as effective Lin AN. Topical calcineurin inhibitors. In: Wolverton SE, editors.
as twice/day; though larger sample size is required to have Comprehensive dermatologic drug therapy, 2 ed. China: Elsevier;2007.p.671-89.
Similarly Schammeret (8) al showed >90% Kino T, Hatanaka H, Hashimoto M, Nishiyama M, Goto T, Okuhara improvement in 51% of patient with 0.03% ointment M, Kohsaka M, Aoki H, Imanaka H. "FK-506, a novel twice/d application. My study showed > 90% immunosuppressant isolated from a Streptomyces. I. Fermentation, improvement in 57.14 %( 0.03% ointment) and 50 %( isolation, and physio-chemical and biological characteristics."JAntibiot (Tokyo) 1987; 40(9):1249–55.
0.1% ointment) of patients. So we can say that once/d Sehgal VN, Srivastava G, Dogra S. Tacrolimus in dermatology- application may be as effective as twice/day.
pharmacokinetics, mechanism of action, drug interactions, dosages,and side effects: part-I. Skinmed.2008; 7:27-30.
As compare to study by Jain S. Et al (9) my study did not show any response in GA, may be due to application used Macrolactumimmunomodulators for topical treatment of inflammatory skin diseases. J Am AcadDermatol 2001; 45:736-43.
Gupta AK, Adamiak A, Chow M. Tacrolimus: a review of its use for Though number of patient was few in my study, results the management of dermatoses. J Eur Acad Dermatol Venereol were comparable to study by Schilieman et al (10) for hand Hanifin JM et al. Tacrolimus in atopic dermatitis: long term efficacy and safety. J AM Acad Dermatol. 2005; 53(2 suppl2):S186-94.
Total response rate and duration for response in present Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E. Tacrolimus study for vitiligo group were comparable to study by XuAE ointment for the treatment of atopic dermatitis in adults patients:Part I, efficacy. J Am AcadDermatol 2001; 44(1 Suppl):S28-38.
et al (11). My study also showed greater response in lesions Schachner LA, Lamerson C, Sheehan MP et al. Tacrolimus ointment on head and neck as in Xu AE et al. Response rate in 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients: results from randomized, double-blind, vehicle controlled study. Paediatrics 2005; 116:e334-e342.
acrofacialis group was less in my study compared to same.
Jain S, Stephens CJ. Successful treatment of disseminated As compare to Hodgson TA et al(13) and Vente C. et al(14) my granuloma annulare with topical tacrolimus. Br J Dermatol 2004;150:1042-3.
study did not showed complete improvement in any 10. Schliemann S, Kelterer D, Bauer A, et al. Tacrolimus ointment in the patient of oral erosive LP group, may be because, in treatment of occupationally induced chronic hand dermatitis.
present study only 0.03% topical tacrolimus was used and Contact Dermatitis 2008; 58(5):299-306.
that also only once/day. Even mean duration of partial 11. Xu AE, Zhang DM, Wei XD, Huang B, Lu LJ. Efficacy and safety of tarcrolimus cream 0.1% in the treatment of vitiligo. Int J Dermatol.
response was also higher in my study. Relapse rate was comparable to study by Vente C et al.
12. Udompataikul M, Boonsupthip P, Siriwattanagate R.Effectiveness of 0.1% topical tacrolimus in adult and children patients with vitiligo. J As compare to other study by BöhmM Et al (n=6) 13. Hodgson TA, Sahani N, Kaliakatsou F et al. Long –term efficacy and group no patient showed complete response, may be safety of topical tacrolimus in the management of ulcerative/erosive because, in present study 0.03% once daily was used and oral lichen planus. Eur J Dermatol. 2003; 13(5):466-70.
14. Vente C, Reich K, Rupprecht R, Neumann C. Erosive mucosal lichen that also for lesser duration. Further study with larger planus: response to topical treatment with tacrolimus. Br J Dermatol 15. Böhm M, Frieling U, Luger TA, Bonsmann G. Successful treatment Anecdotal reports of efficacy of topical tacrolimus in lichen of anogenital lichen sclerosus with topical tacrolimus. Arch planopilaris by Blazek C et al (17) is there. In my study two patient of scarring alopecia were diagnosed as LPP (lichen 16. Luesley DM, Downey GP. Topical tacrolimus in the management of planopilaris). Both of them did not showed any response lichen sclerosus. BJOG 2006; 113:832-834.
17. Blazek C, Megahed M. Lichen planopilaris. Successful treatment with tacrolimus. Hautarzt. 2008; 59(11):874-7.
Anecdotal reports of efficacy of topical tacrolimus in 18. Lampropoulos CE, Sangle S, Harrison P et al.topicaltacrolimus therapy of resistant cutaneous lesions in lupus eryhtematosus: a possible alternative. Rheumatology (Oxford) 2004; 43(11):1383-5.


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