Efficacy Of Topical Tacrolimus Research Articles

Efficacy and safety of topical tacrolimus 0.03% ointment in thygeson superficial punctate keratitis.

Objective: To assess the effectiveness of topical tacrolimus (TCL) 0.03% dermatological ointment in the treatment of patients with Thygeson superficial punctate keratitis. Study Design: Retrospective Review. Setting: Eye OPD of Qazi Hussain Ahmad Medical Complex, Nowshera. Period: Jan 2019 to Jan 2021. Material & Methods: Twelve patients with Thygeson superficial punctate keratitis (TSPK) were included retrospectively by reviewing their medical records. Eight patients were unresponsive to topical steroids and/or lubricants. Diagnosis was made based on the history and clinical findings. All patients were treated with topical tacrolimus 0.03% dermatological ointment twice a day. We took the following subjective features for assessment i.e. watering of eyes and light sensitivity, while for objective features reduction in the no. of epithelial keratitis, healing of keratitis, surface leveling of the lesion and reduced corneal staining with fluorescein. Results: Out of total 12 patients, 4 were male and 8 females with a mean age of 21 ± 9.42 years. All were having bilateral involvement. Duration of therapy ranged from 02 to 40 weeks (mean 08 weeks). All patients improved symptomatically with resolution of watering of eyes and light sensitivity, while in ocular signs we noted improvement in corneal lesions. The efficacy of therapy was observed 3 days, post application among all patients. No, side effects reported in any of our patients treated with topical TCL dermatological ointment. Conclusion: The safety and efficacy of topical tacrolimus 0.03% dermatological ointment has been observed in patients with Thygeson superficial punctate keratitis who were refractory to conventional therapy.

Safety and efficacy of topical tacrolimus 0.03% in the management of vernal keratoconjunctivitis: a non-randomized controlled clinical trial.

Vernal keratoconjunctivitis (VKC) is a bilateral, recurrent, chronic conjunctival inflammatory disease with seasonal exacerbations. This study aimed to assess the efficacy and safety of tacrolimus 0.03% eye ointment in the management of chronic VKC. This was an open-label, prospective, non-randomized, comparative interventional study that enrolled 50 patients with chronic VKC, who were allocated to one of two groups. The first group was treated with tacrolimus 0.03% eye ointment twice daily for 2 months then once daily for 2 months, followed by once every other day for another 2 months. The control group was treated with standard anti-allergic drugs, topical fluorometholone 0.1% eye drops three times daily for 2 weeks and gradually tapered for another 2 weeks, with topical olopatadine 0.1% administered twice daily during the follow-up period. Disease severity was assessed using a four-point scale for symptoms and signs. Treatment efficacy was assessed by analyzing changes in symptoms and signs, and by clinical photography. Fifty patients with bilateral chronic VKC completed the follow-up. The mean (standard deviation) ages of the tacrolimus and control groups were comparable (16.20 [5.10] years versus 16.48 [4.19] years, P > 0.05). The most commonly reported symptom was itching, and the most common signs were papillary hypertrophy and conjunctival hyperemia. All symptoms and signs were significantly reduced after treatment in both groups. The tacrolimus group showed a more significant improvement at 3 and 6 months in the mean composite symptom score (both P < 0.05) and in the mean composite sign score (both P < 0.05). Regarding complications, one case of increased intraocular pressure occurred in the control group (4%) after 2 weeks of steroid treatment, while there were no complications in the tacrolimus group, except for some reports of stinging sensation, which was well tolerated. Treatment of chronic bilateral VKC with tacrolimus 0.03% eye ointment is effective and safe. It could be considered an alternative treatment to reduce steroid-associated complications in patients with chronic VKC. Future double-blinded clinical trials with a longer follow-up period are necessary to confirm our findings and to determine the long-term safety of topical tacrolimus 0.03% ointment in VKC.

Efficacy of topical tacrolimus 0.03% monotherapy in the treatment of non-segmental vitiligo: a randomized, controlled trial.

Topical tacrolimus is increasingly used nowadays in the treatment of vitiligo. We evaluated therapeutic outcomes of tacrolimus 0.03% in non-segmental vitiligo (NSV). Sixty-three patients with NSV were divided into groups A and B. Group A received 0.03% tacrolimus ointment (n=31) and group B received 1% hydrocortisone acetate ointment (n=32) for 24weeks. Vitiligo area and severity index (VASI) and repigmentation rates were determined at baseline and 4-week intervals. In group A, 24-week VASI [0.5 (0.3, 1.95)] was significantly lower than baseline VASI [0.75 (0.5, 2.1); p=0.030]. In group B, 24-week VASI [0.75 (0.4, 2.3)] was not significantly different from baseline VASI [0.73 (0.4, 2.1); p=0.111]. Repigmentation was observed in 14/31 (45.2%) of patients in group A versus 0/32 (0.0%) in group B (p<0.001). Repigmentation was graded as poor in 6/31 (19.4%), fair in 4/31 (12.9%), good in 1/31 (3.2%), and excellent in 3/31 (9.7%). Repigmentation was achieved in 45% of patients with NSV following treatment with tacrolimus 0.03% monotherapy for 24weeks. Tacrolimus-induced repigmentation is more likely in patients with vitiligo vulgaris, head and neck lesions, skin phototype III, and young age.

Comparison of the Efficacy of Topical Tacrolimus, Pimecrolimus, Methylprednisolone Aceponate and Narrow Band UVB in the Treatment of Vitiligo

Comparison of the Efficacy of Topical Tacrolimus, Pimecrolimus, Methylprednisolone Aceponate and Narrow Band UVB in the Treatment of Vitiligo

Efficacy of tacrolimus eyedrops topical application for herpes simplex disciform stromal keratitis and its influence on tear

Background Herpes simplex virus (HSV) disciform stromal keratitis is a T cell-mediated delayed-type hypersensitivity of corneal stroma.The treatment of HSV disciform stromal keratitis is the combination of glucocorticoid and antiviral drug before.However, the therapy is limited for intolerantble patients to glucocorticoid.In addition, the adverse reactions following usage of glucocorticoid can not be ignored.FK506 solution is proved to has the immunosuppressive and antiinflammatory acttions with less side effects than glucocorticoid drug.But the study on the application of FK506 solution in treatment of HSV disciform stromal keratitis is lack. Objective This prospective clinical trail was to evaluate the efficacy of topical tacrolimus for HSV disciform stromal keratitis and its safety. Methods A prospective study was performed on 18 consecutive cases (18 eyes) who were diagnosed as active HSV disciform stromal keratitis from June 2011 to June 2012 in Zhongshan Ophthalmic Center under the approval of the Ethic Committee of Zhongshan Ophthalmic Center and informed consent of the patients, including 3 patients with refractory to prior steroid eyedrops.All patients received a combination topical tacrolimus eyedrops 4 times per day with topical and systemic anti-viral therapy for mean (56.0±7.9)days.Corneal thickness by slit lamp biomicroscope, visual acuity, intraocular pressure, corneal fluorescein staining, SchirmerⅠtest (SⅠt) and tear break-up time (BUT) were performed on the patients before and 1 month, 2 months after treatment and at the drug withdrawal to assess the treating efficacy of FK506, and the adverse reactions of eyes were recorded. Results Corneal edema was alleviated in (8.3±2.5)days after treatment in all the patients and returned to normality in (25.3±11.5) days.Corneal edema of 2 eyes with refractory to previous steroid eyedrops showed a slower recovery procedure than that of the others.Corneal fluorescence staining scores were 4(6, 2), 1(2, 1), 1(1, 0) and 0(1, 0) before and 1 month, 2 months and at drug withdrawal, respectively, with a significant difference among the four time points (H=39.90, P<0.001), and the scores were significantly lower after treatment than before (all at P<0.01).The SⅠt values were (6.78±1.90), (7.39±3.53), (8.06±2.92) and (8.11±3.05)mm/5 min, respectively in the 4 time points, without statistically significant difference among various time points (F=0.94, P=0.43).The BUT values were (0.39±0.50), (1.11±0.90), (2.00±1.08) and (3.39±0.92)seconds, respectively, showing a significant difference among the 4 time points (F=34.54, P<0.01) and had the increased values after treatment of FK506.Recurrence was seen in 2 eyes in 2 months and 5 months after cessation of tacrolimus.However, the eyes were healed after a second round regimen.No elevation of intraocular pressure and secondary infection were found in the patients during the treatment and follow-up period. Conclusions The combination therapy of tacrolimus with antiviral drug is effective and safe for HSV disciform stromal keratitis by alleviating corneal edema and promoting the rehabilitation of tear film. Key words: Tacrolimus/administration & dosage; Immunosuppressive agents/administration & dosage; Keratitis, herpetic/therapy; Drug administration schedul; Treatment outcome

Efficacy of topical tacrolimus 0.1% in the treatment of vitiligo

A clinical trial was carried out with thirty patients affected with vitiligo. Repigmentation was observed in 26.7% cases on the first follow up visit. At the end of 4th week with tacrolimus ointment in the next visit, it was perceptible in 15 cases 50.1% and after 12 weeks of therapy 83.3% yielded repigmentation. Among those who had repigmentation, 20% had &gt; 75% repigmentation, 23.3% had 50-75% repigmentation. The percentage of repigmentation on head and neck (83.3%) was greater than that on extremities (55.6%). Complete (&gt;75%) repigmentation was 33.3% cases on head and neck and 26.7% along with extremities. A total of 83.3% cases had some repigmentation and among them, 10 cases had focal presentation and 15 cases had generalised or segmental presentation. There was statistically significant (p&lt;0.005) difference observed between presentation and pigmentation. By using topical steroid minimum side effects like pruritus in 6.7% cases and burning in 10% cases were evidenced. This study reflects that tacrolimus ointment 0.1% is an effective topical therapeutic option for vitiligo especially on the head and neck region with minimum side effects.&#x0D; CBMJ 2014 January: Vol. 03 No. 01 P: 4-7

Effectiveness of 0.1% topical tacrolimus in adult and children patients with vitiligo

Topical corticosteroids and phototherapy are the conventional treatments of vitiligo. However, the acrofacial and segmental types are often unresponsive to these treatments. Nowadays, a few studies have been conducted on efficacy of topical tacrolimus in treatment of vitiligo including vulgaris and segmental types. Nevertheless, the acrofacial type has never been investigated with this topical therapy. The aim of our study is to evaluate the effectiveness of 0.1% tacrolimus ointment in patients including all types of vitiligo. Forty-two patients with vitiligo (22 adults, 20 children) were enrolled in this study. They were treated with 0.1% tacrolimus ointment twice daily for 6 months. Of these 42 patients, 38 of them completed the treatment process. The mean age of the patients was 27.8 years. The response rate was 76.09%. The vulgaris and focalis had a maximum response rate of 94.12%. The response rates for segmentalis and acrofacialis were 76.92% and 56.25% respectively. Concerning the response, age groups, types and location of vitiligo, there was significant difference in all variables (P = 0.001, P = 0.001, P = 0.025, respectively). Children had approximately nine times higher odds (95% CI = 1.09, 81.88) of having better response to the treatment than adults. The disease duration of 5 years or less also showed a better response. In conclusion, topical tacrolimus can be used for the treatment of patients with vitiligo. We recommend that, other than in the vulgaris type, topical tacrolimus may be considered as a treatment for two difficult to treat types of vitiligo, acrofacialis and segmentalis, before considering other modalities.

Efficacy of topical tacrolimus 0.3% in clobetasol propionate 0.05% ointment in therapy-resistant cutaneous lupus erythematosus: a cohort study

Despite a range of available topical and systemic therapies, treatment of cutaneous lupus erythematosus (CLE) can be challenging. Objectives. To evaluate the efficacy of a specially formulated preparation of tacrolimus 0.3% in clobetasol propionate 0.05% ointment (TCPO) in the treatment of CLE. Case notes of 13 patients with treatment-resistant CLE (11 discoid LE, 1 systemic LE and 1 subacute cutaneous LE) who had used twice-daily TCPO (TCPO group) were reviewed. These were compared with five similar patients with resistant CLE who had been given 0.1% tacrolimus ointment alone (TO group). In the TCPO group (mean treatment duration 20 months, range 1-72), a good or excellent response was seen in five and six patients, respectively; one patient showed slight improvement. Telangiectasia and acne were observed in two patients. No systemic side-effects were noted. In the TO group (mean treatment duration 6 months, range 1-24), one patient showed good improvement and two showed slight improvement. The results of our small retrospective study suggest that TCPO may be more effective than either 0.1% tacrolimus or clobetasol propionate 0.05% ointment monotherapy in the treatment of recalcitrant CLE. Randomized controlled trials are needed to confirm these preliminary findings.

Efficacy of Topical Tacrolimus 0.1% in Active Plaque Morphea

Tacrolimus, a calcineurin inhibitor, is an immunomodulating and anti-inflammatory drug that inhibits T-cell activation and production of cytokines. The elevated level of cytokines in morphea causes fibroblast proliferation and subsequent overproduction of collagen. Theoretically, tacrolimus could inhibit the pathophysiologic process of morphea. To assess whether tacrolimus 0.1% ointment is an effective treatment for active plaque morphea in a double-blind, placebo (petroleum emollient)-controlled pilot study. Ten patients with active plaque morphea were included. All patients were treated with tacrolimus 0.1% ointment and with an emollient (petrolatum) on two selected morphea plaques, applied twice daily for 12 weeks. Initial and final assessment included surface area measurements, photography, durometer scores, and clinical feature scores. Adverse reactions were recorded. The scleroderma plaques treated with topical tacrolimus 0.1% improved, resulting in a significant reduction in durometer and clinical feature scores. Overall, a significant difference could be found between topical tacrolimus and petrolatum with regard to durometer score (p < 0.005) and the clinical feature score (p = 0.019). In this first double-blind, placebo-controlled pilot study comparing tacrolimus 0.1% ointment with petrolatum in active plaque morphea, tacrolimus 0.1% ointment was shown to be an effective treatment for this condition.

Refractory Erosive Oral Lichen Planus Associated with Hepatitis C: Response to Topical Tacrolimus Ointment

Background: Erosive lichen planus is a painful and disabling disease that is frequently resistant to topical and systemic therapies. Current therapies are considered palliative rather than curative as many patients relapse after discontinuing treatment. An association has been reported between some cases of oral lichen planus (OLP) and chronic hepatitis C infection. Objective: We report on a 51-year-old hepatitis C-positive man with corticosteroid refractory erosive lichen planus of the lip who had a rapid resolution of his lesions following a two-week course of topical 0.1% tacrolimus ointment. The patient remains symptom-free at one year post-treatment. Conclusion: This case supports the safety and efficacy of topical tacrolimus in patients with steroid-refractory OLP associated with chronic hepatitis C.

Refractory Erosive Oral Lichen Planus Associated with Hepatitis C: Response to Topical Tacrolimus Ointment

Erosive lichen planus is a painful and disabling disease that is frequently resistant to topical and systemic therapies. Current therapies are considered palliative rather than curative as many patients relapse after discontinuing treatment. An association has been reported between some cases of oral lichen planus (OLP) and chronic hepatitis C infection. We report on a 51-year-old hepatitis C-positive man with corticosteroid refractory erosive lichen planus of the lip who had a rapid resolution of his lesions following a two-week course of topical 0.1% tacrolimus ointment. The patient remains symptom-free at one year post-treatment. This case supports the safety and efficacy of topical tacrolimus in patients with steroid-refractory OLP associated with chronic hepatitis C.

Tacrolimus ointment 0.1% in the treatment of nickel-induced allergic contact dermatitis

Background Tacrolimus is a macrolactam that prevents the transcription of messenger RNA for various inflammatory cytokines in both helper T cells (types 1 and 2) (T H1 and T H2). It is currently approved for the treatment of moderate to severe atopic dermatitis, a Th2-mediated disease, in children and adults. Objective We sought to evaluate the safety and efficacy of tacrolimus ointment 0.1% in the treatment of nickel-induced allergic contact dermatitis, a T H1-mediated disease. Methods This was a double-blind, randomized, vehicle-controlled, bilateral paired comparison study to assess the safety and efficacy of topical tacrolimus (Protopic, Fujisawa Healthcare Inc, Deerfield, Ill) ointment 0.1% in the treatment of allergic contact dermatitis induced by nickel sulfate. Volunteers were individuals with known hypersensitivity to nickel. Reactivity to nickel was graded both as the investigator's global assessment and total signs and symptoms, which consisted of the cumulative grade from 0 to 4 for each of the following parameters: erythema, induration, vesiculation, and pruritus (range of scores: 0-16). Reactivity was assessed in the per-protocol group at 1 and 2 weeks after beginning treatment with study drug and control. Adverse events were assessed in the intent-to-treat population. Results Of the 19 volunteers who completed the study (per protocol), 18 had an improvement in total signs and symptoms with tacrolimus versus 10 patients with the vehicle. Of patients, 80% had an improvement in the investigator's global assessment score on the tacrolimus-treated site versus 30% of patients on the placebo-treated site. Overall, tacrolimus was more effective than placebo in ameliorating the nickel reaction. Although the tacrolimus treated site was clear or almost clear in a greater number of individuals at week 1, this difference did not become significant until the second week of the study. Other than application site burning in 25% of volunteers, no significant adverse events were noted in the intent-to-treat population. Conclusion Topical tacrolimus (Protopic, Fujisawa Healthcare Inc) ointment 0.1% may be an option for the treatment of allergic contact dermatitis induced by nickel.

Topical tacrolimus Protopic(R)

Topical tacrolimus is the first topical immunomodulator of its kind, and its mechanism of action, pharmacokinetics, metabolism and efficacy will be discussed. Multiple studies have supported the safety and efficacy of topical tacrolimus in the treatment of atopic dermatitis in both adults and children. Studies have also suggested that topical tacrolimus may be effective in the treatment of acute contact dermatitis. Although oral administration of tacrolimus proved to be efficacious in psoriasis, results with topical tacrolimus have been disappointing in some studies. Additional reports of success in the use of topical tacrolimus in the treatment of pyoderma gangrenosum show promise, although there is a paucity of randomized, placebo-controlled trials examining its use. It has also been suggested that topical tacrolimus is useful in the treatment of alopecia areata, erosive lichen planus, isolated ichthyosis linearis circumflexa, steroid-induced rosacea, and in the prevention of allograft rejection, however more clinical trials need to be performed.