Efficacy Of Topical Tacrolimus Ointment Research Articles

Comparison between uses of topical tacrolimus and triamcinolone ointment for the treatment of oral lichen planus.

Background: Lichen planus is a chronic mucocutaneous disease with primary or secondary involve- ment of the oral mucosa. In particular in case of erosive lichen planus most of the patients experience no long term symptoms relief of conventional topical treatment such as corticosteroid ointment. Topical tacrolimus applications to mucosal lesions seem to be an alternative treatment approach.Objective: The aim of this study was to compare the efficacy of topical tacrolimus ointment with that of triamcinolone acetonide ointment on patients suffering from oral lichen planus.Study design: This was a clinical trial. Study setting and period: This study was conducted in outpatient department of Oral and Maxillofacial Surgery, Dhaka Dental College in the period between June 2013 to May 2014.Subjects: A total of sixty patients were enrolled. Out of sixty patients thirty patients used topical tacroli- mus 0.03% (Group A) and another thirty patients used topical triamcinolone acetonide( Group B) for the treatment of oral lichen planus.Methods: A total of sixty patients were asked to answer a questionnaire regarding the degree of pain and burning sensation in every two weeks according to visual analogue scale (VAS). In every two weeks change of colour and size and also any side effects of these drugs were assessed. Data were analyzed using Statistical Package for Social Science (SPSS), version 15.0 for windows.Results: At the end of 12th week follow up periods complete relief of pain and burning sensation in group A patients were 100% and in group B it was 30%. There was no side effect in two study group patients.Update Dent. Coll. j: 2018; 8 (1): 17-21

Efficacy of Topical Tacrolimus 0.03% Ointment for Treatment of Allergic Conjunctivitis

Introduction: Allergic conjunctivitis is the most common allergic ocular disorder that is closely related to cell-mediated immunity and activator cytokines. Tacrolimus is a macrolide antibiotic which inhibits T-cell and cellular immunity. The purpose of this study was to evaluate the efficacy of topical tacrolimus ointment on allergic conjunctivitis. Materials & methods: In this clinical trial, 202 patients with allergic conjunctivitis in Arak Imam Reza clinic were randomly divided into two groups including: 1- Standard treatment, 2- standard treatment plus tacrolimus. Three clinical symptoms, i.e. pruritus, pain and photosensitivity were evaluated by visual analog scale (VAS) and two signs, i.e. edema and erythema based on examination before and a month after treatment were compared. Findings: Mean of VAS score for pruritus, pain and photosensitivity were significantly lowered after treatment by tacrolimus than standard group (p<0.05). Erythema and edema were significantly improved by tacrolimus, too. (p <0.05) Discussion & conclusions: Adding topical tacrolimus ointment to standard treatments is very effective in allergic conjunctivitis and in severe cases it can be used.

Early Aggressive Treatment of Lichen Sclerosus May Prevent Disease Progression

When not recognized and treated aggressively, lichen sclerosus may progress and cause debilitating symptoms. It also may result in significant morbidity in patients undergoing treatment for urethral strictures because unrecognized, it may result in rapid and severe recurrence after surgical treatment. We present our experience treating patients with lichen sclerosus in an equal access health care system. We performed an institutional review board approved retrospective review of all adult men with lichen sclerosus treated at our institution during a 10-year period. We analyzed all patients diagnosed with lichen sclerosus, and recorded patient demographics and therapies. We recorded characteristics of the disease process including external and internal manifestations. We also recorded the various treatments, and whether the patients experienced recurrence. A total of 43 patients were diagnosed with lichen sclerosus during the review period. Of those patients presenting with more severe (urethral) involvement and undergoing 1 or 2-stage urethroplasties, we noted 7 with recurrence. In the remainder of patients presenting with less severe disease who were treated aggressively with clobetasol and/or minor procedures, no recurrences were noted on followup examination, and all of these patients had documented normal flow patterns on noninvasive urodynamics. Our data suggest that early aggressive topical therapy plus minimally invasive surgical therapy to relieve high pressure voiding may prevent the progression of lichen sclerosus in patients who present with limited disease involving the skin and meatus.

What’s new in atopic eczema? An analysis of systematic reviews published in 2007 and 2008. Part 2. Disease prevention and treatment

This review summarizes clinically important findings from systematic reviews indexed in bibliographical databases between August 2007 and August 2008 that dealt with disease prevention (six reviews) and treatment of atopic eczema (seven reviews). Regarding disease prevention, two independent systematic reviews found some clinical trial evidence that ingestion of probiotics by mothers during pregnancy might reduce the incidence of subsequent eczema. Another review failed to find any clear benefit of prebiotics in eczema prevention. Although furry pets are often cited as causing allergic disease, a systematic review of observational studies found no evidence that exposure to cats or dogs at birth increases eczema risk. One very large review of studies of breastfeeding found some evidence of a protective effect on eczema risk, although all the studies were limited by their observational nature. A German group has attempted an overview of eczema prevention studies with a view to informing national guidelines. In terms of eczema treatment, two systematic reviews have confirmed the efficacy of topical tacrolimus ointment. Another review of 31 trials confirms the efficacy of topical pimecrolimus, although many of those trials were vehicle controlled, which limits their clinical utility. A review of 23 studies of desensitization therapy for allergic diseases found some evidence of benefit for eczema, which needs to be explored further. Despite the popularity of antistaphylococcal therapies for eczema, a Cochrane Review of 21 trials failed to show any clear benefit for any of the therapies for infected or clinically noninfected eczema. Another Cochrane Review dealt with dietary exclusions for people with eczema and found little evidence to support any dietary exclusion, apart from avoidance of eggs in infants with suspected egg allergy supported by evidence of sensitization. A review of 13 studies of probiotics for treating established eczema did not show convincing evidence of a clinically worthwhile benefit, an observation that has been substantiated in a subsequent Cochrane Review.

Efficacy and safety of tarcrolimus cream 0.1% in the treatment of vitiligo

Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. Phototherapy and application of topical corticosteroids are most commonly prescribed. However, these therapies are often not effective and use of corticosteroids on the face may lead to cutaneous atrophy, telangiectasia, and ocular complications. We sought to assess the efficacy of topical tacrolimus ointment in the treatment of vitiligo. A prospective pilot study was performed of 30 patients with vitiligo. Patients were treated with tacrolimus ointment for at least 4 months. Clinical responses were documented during clinic visits, and by pretacrolimus and post-tacrolimus photography. Twenty-five (83.3%) patients showed some repigmentation at the end of 4 months. Patients with vitiligo for more than 5 years also responded well to tacrolimus ointment. Repigmentation in active vitiligo was superior to that in stable vitiligo. 80% of patients with segmental vitiligo of the head and neck showed some response to tacrolimus, but there was no statistical significance between segmental and vulgaris vitiligo. The mean percentage of repigmentation on the head and neck was greater than that on the trunk and extremities. Four patients initially experienced burning on application. Topical tacrolimus ointment is an effective and well-tolerated alternative therapy for vitiligo especially involving the head and neck.

Topical tacrolimus 0.1% ointment in the treatment of localized scleroderma. An open label clinical and histological study

Localized scleroderma or morphea, although a self-limited and benign disease, may leave substantial physical and cosmetic deformity necessitating treatment but treatment remains to date unsatisfactory. The aim of our study was to evaluate the efficacy of topical tacrolimus ointment in the treatment of morphea. Thirteen patients with morphea used tacrolimus 0.1% cream b.i.d. without occlusion for 4 months. Patients were followed up for up to a year. A 4-mm biopsy was taken before starting treatment in seven patients and 4 months after continuous use of tacrolimus 0.1% ointment, next to the previous biopsy site. Masson trichrome and elastica stains were performed to evaluate the distribution of elastic fibers as well as the streptavidin-biotin horseradish peroxide immunohistochemical method for the detection of CD20/L-26, CD3, CD8, CD4, CD1a, human leukocyte antigen-DR and CD25. Four patients had a less than 25% improvement, two patients responded by 50-70% and the remaining seven by more than 70%. Patients with thick, well-established lesions responded poorly in comparison to others with less thick and more erythematous ones. Patients with mild-to-moderate fibrosis histologically were more likely to improve after treatment, while the lymphocytic infiltrate decreased regardless of initial degree before treatment. It was concluded that topical tacrolimus 0.1% cream may be used in patients with morphea, particularly with early inflammatory lesions, even as a first-line treatment.

Efficacy and Tolerability of Topical Tacrolimus Ointment for the Treatment of Male Genital Psoriasis

Genital psoriasis is difficult to treat and has a significant psychological impact on affected patients. To study the safety and efficacy of topical tacrolimus ointment in male patients with genital psoriasis. This was an open-label study in 12 male patients with genital psoriasis. Patients received topical tacrolimus 0.1% ointment twice daily for 8 weeks followed by a 4-week observational period. Efficacy was assessed by a modification of the Psoriasis Area and Severity Index (PASI) scale adapted for genital psoriasis (male genital PASI). Severity was also evaluated individually for the glans, shaft of the penis, and scrotum. Male genital PASI decreased from a mean score of 15.8 at baseline to 1.2 at week 8 (p < .001). Psoriasis severity also improved significantly for the glans, shaft of the penis, and scrotum evaluated individually. Tacrolimus 0.1% ointment was very well tolerated, with only mild pruritus or burning sensation of limited duration reported. Topical tacrolimus ointment appears very efficacious and well tolerated in male patients with genital psoriasis.

Oral graft vs. host disease in children – Treatment with topical tacrolimus ointment

Oral chronic graft vs. host disease (GVHD) frequently presents in patients with sclerotic features of skin GVHD and is often associated with considerable limitations of oral food intake and decreased quality of life. Systemic tacrolimus is efficacious for prophylaxis and treatment of acute and chronic GVHD and topical tacrolimus has shown activity in chronic GVHD skin lesions. We therefore initiated a pilot study to investigate the safety and efficacy of topical tacrolimus ointment in children with oral GVHD. Six patients suffering from oral GVHD (five chronic and one acute) were included in the study. Tacrolimus ointment 0.1% was applied twice daily using sterile gauze. The only side-effects observed were a slight burning discomfort after the first application in one patient and after food intake in another patient. Tacrolimus was absorbed systemically in four of six patients. Of six patients, we observed a complete response in two, a very good partial response (VGPR) in two, and a PR in two patients, respectively. We conclude that topical application of tacrolimus ointment holds promise as a safe and efficacious treatment for oral GVHD in children. The Food and Drug Administration has recently issued a health advisory about a potential cancer risk associated with topical tacrolimus treatment of the skin; therefore, its benefits should be weighed against its potential risks and diligent long-term follow-up should be carried out especially in children.

Multicentre, phase II trial on the safety and efficacy of topical tacrolimus ointment for the treatment of lichen sclerosus

Lichen sclerosus is a chronic inflammatory autoimmune disease causing significant sclerosis, atrophy and pruritus. Treatment remains unsatisfactory, with potent corticosteroids being the most effective therapy. To conduct a multicentre, phase II trial to assess the safety and efficacy of tacrolimus ointment 0.1% for the treatment of lichen sclerosus with a follow-up period of 18 months at 10 university and teaching hospitals in Germany and Austria. Eighty-four patients (49 women, 32 men and three girls) aged between 5 and 85 years with long-standing, active lichen sclerosus (79 with anogenital and five with extragenital localization) were treated with topical tacrolimus ointment 0.1% twice daily for 16 weeks. Computerized analysis of the lesional area was performed. The primary endpoint was clearance of active lichen sclerosus. Secondary endpoints were time to optimal response, reduction of sclerosis and duration of remission. The primary endpoint (clearance of active lichen sclerosus) was reached by 43% of patients at 24 weeks of treatment. Partial resolution was reached in 34% of patients. Maximal effects occurred between week 10 and 24 of therapy. Treatment led to a significant reduction of the total lesional area (P < 0.01) and to a significant decline in the total symptom score (P < 0.005). Symptoms (e.g. itching) and findings (erythema, erosions and induration) showed significant improvement. No serious adverse events were observed. There were three (9%) recurrences during the follow-up period. Topical tacrolimus ointment 0.1% was safe and effective for the treatment of long-standing active lichen sclerosus.

Oral chronic GVHD in children—treatment with topical tacrolimus ointment

Oral chronic graft versus host disease (GVHD) frequently presents as lichen-type changes, hyperkeratotic plaques, pseudomembranes, or decreased oral range of motion in patients with sclerotic features of skin GVHD and is often associated with significant limitations of oral food intake and a generally decreased quality of life. Decreased oral intake is especially problematic in children with already reduced caloric uptake due to chronic gastrointestinal GVHD. Systemic tacrolimus is well established and efficacious for prophylaxis and treatment of acute and chronic GVHD and topical tacrolimus has shown activity in chronic GVHD skin lesions. We therefore initiated a pilot study to investigate the safety and efficacy of topical tacrolimus ointment in pediatric stem cell transplant recipients with debilitating oral chronic GVHD. Two patients (6 and 13 years) with β-thalassemia were included in the study at 179 and 382 days post transplant respectively. Both suffered from progressive onset, moderate to severe chronic GVHD with involvement of the oral mucosa exhibiting lichen-type changes alongside pain, erythema and small ulcerations of the oral mucosa. One patient additionally presented with progressive sclerosis of the lips limiting opening of the oral cavity. In both patients oral lesions had been refractory to systemic GVHD treatment (cyclosporine 3 and 2 mg/kg respectively). After exclusion of infectious causes for oral lesions, tacrolimus ointment 0.1% (Protopic®, Fujisawa Healthcare) was applied twice daily using a sterile gauze that was inserted into both buccal pouches and left in place for 20 minutes without rinsing the mouth afterwards. At a follow up of 24 and 14 weeks respectively, the only side effect observed was a slight burning discomfort after the first application in one patient. Tacrolimus was absorbed in both patients as exhibited by tacrolimus plasma levels up to 4.2 and 5.6 ng/ml respectively. Pain, erythematous lesions and ulcerations disappeared within 4 weeks of treatment in both. Lichenoid changes markedly improved in both and range of oral opening normalized in the patient affected. Systemic immunosuppression was tapered during treatment with topical tacrolimus in both patients. We conclude that topical application of tacrolimus ointment holds promise as a safe and efficacious treatment for oral chronic GVHD in children. These findings deserve to be affirmed in a larger prospective evaluation. Oral chronic graft versus host disease (GVHD) frequently presents as lichen-type changes, hyperkeratotic plaques, pseudomembranes, or decreased oral range of motion in patients with sclerotic features of skin GVHD and is often associated with significant limitations of oral food intake and a generally decreased quality of life. Decreased oral intake is especially problematic in children with already reduced caloric uptake due to chronic gastrointestinal GVHD. Systemic tacrolimus is well established and efficacious for prophylaxis and treatment of acute and chronic GVHD and topical tacrolimus has shown activity in chronic GVHD skin lesions. We therefore initiated a pilot study to investigate the safety and efficacy of topical tacrolimus ointment in pediatric stem cell transplant recipients with debilitating oral chronic GVHD. Two patients (6 and 13 years) with β-thalassemia were included in the study at 179 and 382 days post transplant respectively. Both suffered from progressive onset, moderate to severe chronic GVHD with involvement of the oral mucosa exhibiting lichen-type changes alongside pain, erythema and small ulcerations of the oral mucosa. One patient additionally presented with progressive sclerosis of the lips limiting opening of the oral cavity. In both patients oral lesions had been refractory to systemic GVHD treatment (cyclosporine 3 and 2 mg/kg respectively). After exclusion of infectious causes for oral lesions, tacrolimus ointment 0.1% (Protopic®, Fujisawa Healthcare) was applied twice daily using a sterile gauze that was inserted into both buccal pouches and left in place for 20 minutes without rinsing the mouth afterwards. At a follow up of 24 and 14 weeks respectively, the only side effect observed was a slight burning discomfort after the first application in one patient. Tacrolimus was absorbed in both patients as exhibited by tacrolimus plasma levels up to 4.2 and 5.6 ng/ml respectively. Pain, erythematous lesions and ulcerations disappeared within 4 weeks of treatment in both. Lichenoid changes markedly improved in both and range of oral opening normalized in the patient affected. Systemic immunosuppression was tapered during treatment with topical tacrolimus in both patients. We conclude that topical application of tacrolimus ointment holds promise as a safe and efficacious treatment for oral chronic GVHD in children. These findings deserve to be affirmed in a larger prospective evaluation.

A Comparison of Treatment of Oral Lichen Planus with Topical Tacrolimus and Triamcinolone Acetonide Ointment

Treatment of symptomatic oral lichen planus remains a challenging problem. This study compared the efficacy of topical tacrolimus ointment with triamcinolone acetonide ointment in patients with oral lichen planus. Twenty patients (group I) were treated with topical tacrolimus 0.1% ointment 4 times daily, and 20 (group II) were treated with triamcinolone acetonide 0.1% ointment 4 times daily. The clinical effect was graded after 6 weeks. In group I, 6 patients healed, 12 showed improvement and 2 showed no improvement. In group II, 2 patients healed, 7 improved and 11 showed no improvement. The most commonly reported side-effect in both groups was temporary burning or stinging at the site of application. Unfortunately, oral lesions recurred within 3-9 weeks of cessation of treatment in 13 of the 18 patients who had initially shown an improvement or were healed in group I and in 7 of the 9 patients in group II. Topical tacrolimus 0.1% ointment induced a better initial therapeutic response than triamcinolone acetonide 0.1% ointment. However, relapses occurred frequently within 3-9 weeks of the cessation of treatment.

Tacrolimus ointment promotes repigmentation of vitiligo in children: A review of 57 cases

Vitiligo is an autoimmune disorder characterized by loss of pigmentation. Phototherapy and application of topical corticosteroids are most commonly prescribed. However, these therapies are often not effective and use of corticosteroids on the face may lead to cutaneous atrophy, telangiectasia, and ocular complications. We sought to assess the efficacy of topical tacrolimus ointment in the treatment of pediatric vitiligo. A retrospective review was performed of 57 pediatric patients with vitiligo at two clinical sites. Patients were treated with tacrolimus ointment for at least 3 months. Clinical responses were documented during clinic visits, and by pretacrolimus and posttacrolimus photography. At least partial response was noted to tacrolimus ointment on the head and neck in 89%, and on the trunk and extremities in 63% of patients. Facial vitiligo of the segmental type showed the best response rate. Two patients initially experienced burning on application. Topical tacrolimus ointment is an effective alternative therapy for childhood vitiligo, particularly involving the head and neck.

FC‐21 Efficacy of topical tacrolimus ointment for treatment of plantar fistulae in German shepherd dogs

The objective of this open pilot study was to evaluate the efficacy of topical tacrolimus ointment for treatment of plantar fistulae in German shepherd dogs. Seven dogs (four males, three females) were included. All subjects had a 6‐month to 2‐year history of plantar fistulae involving the plantar aspect of two to four metatarsi/metacarpi. No other skin lesions were present and the dogs appeared otherwise healthy. Before treatment with tacrolimus, all dogs received antibiotics for 4–8 weeks. Hair was clipped to visualise the lesions. The presence of erythematous papules, oedema and fistulae was recorded for each foot. All dogs served as their own controls. Dogs with four legs involved had one front and one hind leg treated. Dogs with two to three feet affected had only one foot treated. Tacrolimus 0.1% ointment (Protopic®) was applied twice daily onto the site of lesions. Partial improvement of treated lesions was seen in all cases within 3 weeks. After 6 weeks, treated lesions were in complete remission in four dogs, while the other three subjects had palpable but invisible lesions. Signs had not improved on the untreated legs. Follow‐up varied between 4 months and 2 years. Lesion remission persisted in six dogs with the intermittent application of tacrolimus. Adverse effects of treatment were not seen. In conclusion, the application of topical tacrolimus seems to provide a safe and effective treatment option for plantar fistulae in German shepherd dogs. Funding: Self‐funded.