tacrolimus and Lichen-Sclerosus-et-Atrophicus

Lichen sclerosus is one of the dermatoses that specifically affects the anogenital skin. It has peaks of incidence in prepubertal girls and postmenopausal women. The objective of this critical appraisal was to review systematically the evidence for efficacy and safety of different treatments. There are no randomized controlled studies of treatment in prepubertal girls and most studies are small case series or case reports. There is little focus on quality of life.

Topics: Administration, Topical; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Ointments; Steroids; Tacrolimus; Treatment Outcome; Vulvar Diseases

Inflammatory mucosal disorders are treated conventionally with potent or superpotent topical corticosteroids. For more than 20 years, topical cyclosporine has been used in the management of oral mucous membrane affections. Recently other topically applied calcineurin inhibitors, namely tacrolimus and pimecrolimus, expanded the armamentarium for the treatment of inflammatory mucosal diseases. This chapter places its main emphasis on the efficacy and safety of topical calcineurin inhibitors in the management of different oral and genital conditions, including anogenital lichen sclerosus (LS), oral and genital lichen planus, plasma cell balanitis and vulvitis, mucous membrane pemphigoid and pemphigus vulgaris, all conditions having usually a protracted course, requiring long-lasting treatment. There is current evidence for the effectiveness of both pimecrolimus and tacrolimus in the topical treatment of inflammatory oral mucosal diseases and genital dermatoses, especially oral lichen planus and genital LS.

Topics: Administration, Topical; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Balanitis; Calcineurin Inhibitors; Carcinogens; Female; Genital Diseases, Female; Humans; Lichen Planus; Lichen Planus, Oral; Lichen Sclerosus et Atrophicus; Male; Mucositis; Paraneoplastic Syndromes; Pemphigoid, Benign Mucous Membrane; Pemphigus; Tacrolimus; Vulvitis

Lichen sclerosus is a chronic, inflammatory skin condition that most commonly occurs in adult women, although it may also be seen in men and children. It primarily affects the genital area and around the anus, where it causes persistent itching and soreness. Scarring after inflammation may lead to severe damage by fusion of the vulval lips (labia); narrowing of the vaginal opening; and burying of the clitoris in women and girls, as well as tightening of the foreskin in men and boys, if treatments are not started early. Affected people have an increased risk of genital cancers.. To assess the effects of topical interventions for genital lichen sclerosus and adverse effects reported in included trials.. We searched the following databases up to 16 September 2011: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2007), LILACS (from 1982), CINAHL (from 1981), British Nursing Index and Archive (from 1985), Science Citation Index Expanded (from 1945), BIOSIS Previews (from 1926), Conference Papers Index (from 1982), and Conference Proceedings Citation Index - Science (from 1990). We also searched ongoing trial registries and scanned the bibliographies of included studies, published reviews, and papers that had cited the included studies.. Randomised controlled trials (RCTs) of topical interventions in genital lichen sclerosus.. Two authors independently selected trials, extracted data, and assessed the risk of bias. A third author was available for resolving differences of opinion.. We included 7 RCTs, with a total of 249 participants, covering 6 treatments. Six of these RCTs tested the efficacy of one active intervention against placebo or another active intervention, while the other trial tested three active interventions against placebo.When compared to placebo in one trial, clobetasol propionate 0.05% was effective in treating genital lichen sclerosus in relation to the following outcomes: 'participant-rated improvement or remission of symptoms' (risk ratio (RR) 2.85, 95% confidence interval (CI) 1.45 to 5.61) and 'investigator-rated global degree of improvement' (standardised mean difference (SMD) 5.74, 95% CI 4.26 to 7.23).When mometasone furoate 0.05% was compared to placebo in another trial, there was a significant improvement in the 'investigator-rated change in clinical grade of phimosis' (SMD -1.04, 95% CI -1.77 to -0.31).Both trials found no significant differences in reported adverse drug reactions between the corticosteroid and placebo groups. The data from four trials found no significant benefit for topical testosterone, dihydrotestosterone, and progesterone. When used as maintenance therapy after an initial treatment with topical clobetasol propionate in another trial, topical testosterone worsened the symptoms (P < 0.05), but the placebo did not.One trial found no differences between pimecrolimus and clobetasol propionate in relieving symptoms through change in pruritus (itching) (SMD -0.33, 95% CI -0.99 to 0.33) and burning/pain (SMD 0.03, 95% CI -0.62 to 0.69). However, pimecrolimus was less effective than clobetasol propionate with regard to the 'investigator-rated global degree of improvement' (SMD -1.64, 95% CI -2.40 to -0.87). This trial found no significant differences in reported adverse drug reactions between the pimecrolimus and placebo groups.. The current limited evidence demonstrates the efficacy of clobetasol propionate, mometasone furoate, and pimecrolimus in treating genital lichen sclerosus. Further RCTs are needed to determine the optimal potency and regimen of topical corticosteroids, examine other topical interventions, assess the duration of remission or prevention of flares, evaluate the reduction in the risk of genital squamous cell carcinoma or genital intraepithelial neoplasia, and examine the efficacy in improving the quality of the sex lives of people with this condition.

Topics: Adult; Anti-Inflammatory Agents; Child; Clobetasol; Dermatologic Agents; Dihydrotestosterone; Female; Genital Diseases, Male; Humans; Lichen Sclerosus et Atrophicus; Male; Mometasone Furoate; Pregnadienediols; Randomized Controlled Trials as Topic; Tacrolimus; Testosterone Propionate; Vulvar Lichen Sclerosus

Management of lichen sclerosus (LS) in boys is still controversial. Although in most cases only the prepuce is affected, meatal and urethral involvement may require major surgical reconstruction with substantial morbidity.. Because the frequency of such complicated courses is still unclear, an adjuvant postoperative treatment is highly desirable. Therefore, we addressed safety and tolerability of tacrolimus 0.1% ointment in the postoperative period.. Among 222 penile surgeries, in 25 cases LS was confirmed histologically and 20 of those patients participated in the adjuvant treatment study. Moreover, 18 patients of the same cohort showed a lichenoid inflammatory reaction pattern suggestive of early but not fully established LS.. Subsequent to the operation and after explicit information about off-label use, parents applied tacrolimus 0.1% ointment twice daily to the glans and the meatus for 3 wk in cases of proven LS. The 18 patients with possible early LS were followed up only without any treatment. Clinical follow-up was performed up to 13 mo (median).. All 20 LS patients completed the topical treatment without any relevant side-effects. Two relapses occurred in the treatment group and were clinically cured with an additional 3-wk cycle of topical tacrolimus 0.1% ointment. None of the 18 early LS cases progressed to full-scale LS.. This is the first study showing that tacrolimus 0.1% ointment applied immediately after surgery of fully established LS is a tolerable and most probably safe adjuvant novel treatment option. Because the therapy led to disease control in all treated individuals for >1 yr (median), this study establishes the groundwork for future trials with expanded treatment and follow-up periods to verify the true clinical benefit of tacrolimus in patients after LS surgery. Lichenoid tissue reactions suggestive of early LS seem to require no adjuvant treatment.

Topics: Administration, Topical; Adolescent; Chemotherapy, Adjuvant; Child; Child, Preschool; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Prospective Studies; Tacrolimus

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.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Autoimmune Diseases; Child; Child, Preschool; Female; Genital Diseases, Female; Genital Diseases, Male; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Middle Aged; Ointments; Severity of Illness Index; Tacrolimus; Treatment Outcome

Topics: Female; Humans; Lichen Sclerosus et Atrophicus; Outcome Assessment, Health Care; Reference Standards; Tacrolimus; Vulvar Lichen Sclerosus

Topics: Child; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Tacrolimus

Topics: Administration, Topical; Child, Preschool; Cone-Beam Computed Tomography; Female; Humans; Lichen Sclerosus et Atrophicus; Maxilla; Maxillary Diseases; Mouth Mucosa; Orthognathic Surgical Procedures; Periodontal Attachment Loss; Tacrolimus; Treatment Outcome

We established diagnostic criteria and severity classification of lichen sclerosus et atrophicus, because there is no established diagnostic criteria or widely accepted severity classification of the disease. Also, there is no clinical guideline for lichen sclerosus et atrophicus in Japan, so we proposed its clinical guideline. The clinical guidelines were formulated by clinical questions and recommendations on the basis of evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guidelines easy to use and reliable including the newest evidence, and to present guidance for various clinical problems in treatment of lichen sclerosus et atrophicus.

Topics: Administration, Cutaneous; Age Factors; Biopsy; Diagnosis, Differential; Female; Glucocorticoids; Humans; Lichen Sclerosus et Atrophicus; Male; Ointments; Phototherapy; Severity of Illness Index; Sex Factors; Skin; Tacrolimus; Treatment Outcome

Lichen sclerosus (LS) is a chronic, inflammatory condition of the skin, affecting primarily the anogenital region potentially leading to changes in vaginal architecture and vulvar squamous cell carcinoma. Current recommended treatment for LS is high-potency corticosteroids. Calcineurin inhibitors may also have a role.. The objective of this study is to introduce a treatment regimen involving clobetasol to induce remission, then tacrolimus to maintain remission in pediatric females with LS.. As a retrospective case series, we report 14 pediatric females between 2 and 10 years of age with LS treated with clobetasol 0.05% topical ointment and systematically bridged to tacrolimus 0.1% topical ointment. For each patient, gender, age at disease onset, and clinical symptoms and features were noted. Time in weeks to 75% clearance and to complete clearance were recorded.. Thirteen patients showed complete clearance. One patient showed significant clearance of the disease. The time to complete clearance averaged 43.1 weeks, with a range of 4-156 weeks.. The use clobetasol to induce remission and tacrolimus to maintain remission can be used to treat LS in pediatric females. This regimen may minimize side effects associated with long-term, high-potency corticosteroid use and reduce the risk of changes to genital architecture secondary to LS.

Topics: Calcineurin Inhibitors; Child; Child, Preschool; Chronic Disease; Clobetasol; Dermatologic Agents; Female; Glucocorticoids; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Retrospective Studies; Tacrolimus

Topics: Administration, Cutaneous; Aged; Cheek; Facial Dermatoses; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Tacrolimus; Telangiectasis

Topics: Abdominal Injuries; Adolescent; Animals; Bites and Stings; Cnidaria; Cnidarian Venoms; Dermis; Diagnosis, Differential; Female; Humans; Immunosuppressive Agents; Lichen Planus; Lichen Sclerosus et Atrophicus; Tacrolimus

Lichen sclerosus is a chronic inflammatory condition affecting the anogenital region that may present in the prepubertal or adolescent patient. Clinical presentations include significant pruritus, labial adhesions, and loss of pigmentation. Treatment includes topical anti-inflammatory agents and long-term follow-up as there is a high risk of recurrence and an increased risk of vulvar cancer in adult women with history of lichen sclerosus. These recommendations are intended for pediatricians, gynecologists, nurse practitioners and others who care for pediatric/adolescent girls in order to facilitate diagnosis and treatment.

Topics: Adolescent; Anti-Inflammatory Agents; Betamethasone Valerate; Child; Clobetasol; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Recurrence; Tacrolimus

To assess the efficacy of clobetasol propionate 0.05% cream in male patients suffering from genital lichen sclerosus (GLS), as well as the efficacy of methylprednisolone aceponate 0.1% cream and tacrolimus 0.1% ointment as maintenance therapy.. The study was conducted retrospectively. At baseline, male patients with GLS (n = 41) were treated with clobetasol propionate 0.05% cream applied twice daily for 8 weeks. Visual Analog Scale (VAS) score for pruritus, Investigator's Global Assessment (IGA) score and Dermatology Life Quality Index (DLQI) were recorded at baseline, week 8 and week 20. At week 8, patients responsive to treatment (n = 37) were further treated with methylprednisolone aceponate 0.1% cream twice weekly (n = 17) or tacrolimus 0.1% ointment once daily (n = 20), as maintenance therapy until week 20.. VAS, IGA and DLQI median scores were significantly decreased from baseline to week 8 (p < 0.001). At week 20, patients treated with methylprednisolone aceponate 0.1% cream presented no significant difference in median IGA score (p = 0.865), median DLQI score (p = 0.853) or median VAS score (p = 0.474) compared with patients treated with tacrolimus 0.1% ointment.. Clobetasol propionate 0.05% cream is effective as first-line treatment in male GLS. The data suggest that there is no difference between methylprednisolone aceponate 0.1% cream and tacrolimus 0.1% ointment in preventing the relapses.

Topics: Adult; Clobetasol; Genital Diseases, Male; Humans; Lichen Sclerosus et Atrophicus; Maintenance Chemotherapy; Male; Methylprednisolone; Pruritus; Quality of Life; Retrospective Studies; Secondary Prevention; Skin Cream; Tacrolimus

To assess the efficacy of methylprednisolone aceponate 0.1% (MPA 0.1%) in female genital lichen sclerosus (GLS) and efficacy of MPA, tacrolimus or emollient for prevention of flares.. A single-center, retrospective study was conducted. At baseline, female patients with relapsing GLS (n = 46) were treated with MPA 0.1% applied once daily for 8 weeks. Visual Analog Scale (VAS) score for vulvar pruritus and Investigator's Global Assessment (IGA) score were recorded at baseline, weeks 8 and 20. At week 8, patients responsive to treatment (n = 38) were further treated with MPA 0.1% twice weekly (n = 15), tacrolimus once daily (n = 13) or topical emollient once daily (n = 10), as maintenance therapy until week 20.. Both VAS and IGA median score was significantly decreased from baseline to week 8 (p = 0.000). At week 20, both median VAS and IGA scores differed significantly between patients treated with emollient and patients treated with MPA 0.1% (p = 0.000) and patients treated with emollient and patients treated with tacrolimus (p = 0.000); patients treated with MPA 0.1% presented no significant difference in either median VAS score (p = 0.032) or median IGA score (p = 0.636) at week 20 compared to patients treated with tacrolimus.. MPA 0.1% is effective in relapsing female GLS. MPA 0.1% and tacrolimus have equal efficacy in preventing relapses.

Topics: Aged; Dermatologic Agents; Emollients; Female; Humans; Lichen Sclerosus et Atrophicus; Methylprednisolone; Middle Aged; Retrospective Studies; Secondary Prevention; Tacrolimus; Treatment Outcome

Lichen sclerosus is a chronic inflammatory dermatosis presenting with significant sclerosis, atrophy and pruritus. The treatment for this condition remains unsatisfactory, with potent corticosteroids being the most effective therapy. In this study, we investigated the efficacy and safety of tacrolimus ointment in patients with genital and extragenital lichen sclerosus. Sixteen patients with active lichen sclerosus (10 with anogenital and six with extragenital localization) were treated with topical tacrolimus ointment twice daily. The therapeutic effects were evaluated according to 3 grades: complete response (>75% improvement), partial response (25-75% improvement), or no response (<25% improvement). Applications were continued until complete disappearance or stabilization of the cutaneous lesions. In addition, we conducted telephone surveys to determine the long-term treatment outcome and relapse rate. Objective response to therapy occurred in nine of 10 patients (90%) with anogenital and one of six patients (16.7%) with extragenital lesions. Out of 10 patients with anogenital lichen sclerosus, five showed more than 75% improvement. Complete, partial and no response were achieved in five (50%), four (40%) and one (10%) patient, respectively. During the follow-up period of a mean of 29.3 months, six of nine patients had a relapse of symptoms. However, most patients with extragenital involvement did not respond to tacrolimus, except one patient showing partial response. No significant adverse effects were observed. Topical tacrolimus ointment was a safe and effective treatment for genital lichen sclerosus and should be used for long-term duration to prevent relapse. However, it was not useful for patients with extragenital lichen sclerosus.

Topics: Adolescent; Adult; Aged; Child; Chronic Disease; Female; Genital Diseases, Female; Genital Diseases, Male; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Middle Aged; Ointments; Tacrolimus; Treatment Outcome; Young Adult

Lichen sclerosus is a chronic inflammatory disease of unknown origin, which affects mostly women in the fifth and sixth decades of life, but can also occur in men and children. The involvement of the oral mucosa alone or together with other forms of presentation is extremely rare, requiring a differential diagnosis with other diseases of the oral cavity, particularly lichen planus. There are less than 30 cases of lichen sclerosus in the oral mucosa described in the literature and there are no reports on malignant transformation so far. We describe a patient with skin, oral and genital lesions of lichen sclerosus.

Topics: Administration, Topical; Aged; Diagnosis, Differential; Female; Genital Diseases, Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Mouth Diseases; Tacrolimus

Lichen sclerosus (LS) is a chronic skin disorder with a predilection for the anogenital area. The disease is mostly seen in prepubertal and postmenopausal females. The lesions present as sharply demarcated white plaques encircling the vagina and anus. The atrophic form can lead to scarring of the affected area.. Retrospective analysis of hospital records of children (aged 1-18 years) seen at the Department of Dermatology and Allergy Centre in Odense from October 1998 to November 2010 with a definite clinical diagnosis of anogenital LS with/without a confirming biopsy.. A total of 35 girls and one boy were diagnosed with anogenital LS. The diagnostic delay was 17 months. Pruritus, dysuria, bleeding and constipation were the dominant complaints, while one patient was asymptomatic. Referral was made by general practitioners, private dermatologists and paediatricians. Sexual abuse was suspected in five cases. Ten patients underwent biopsy confirming LS. Before a definite diagnosis was given, many children were extensively treated with various topical and oral agents. In our outpatient clinic, 30 children were treated with potent/ultra-potent corticosteroids and five patients were treated with calcineurin inhibitors.. General practitioners may overlook this disorder despite characteristic clinical features and effective symptomatic treatment. Diagnostic delay is a significant problem for both patient and family, and the lesions may mimic the findings of sexual abuse. Potent corticosteroids are very effective in symptomatic treatment.. not relevant.

Topics: Adolescent; Adrenal Cortex Hormones; Child; Child, Preschool; Delayed Diagnosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Infant; Lichen Sclerosus et Atrophicus; Male; Retrospective Studies; Tacrolimus; Treatment Outcome; Vulvar Lichen Sclerosus

A major complication following hematopoietic stem cell transplantation is graft versus host disease. Cutaneous manifestations of chronic graft versus host disease (cGVHD) are varied and this condition impacts patient outcomes and quality of life. We describe two cases of lichen sclerosus et atrophicus-like cGVHD developing in patients after hematopoietic stem cell transplantation. Both patients presented clinically with patches of pigmentary changes and scaling that displayed classic histologic features of lichen sclerosus et atrophicus. The skin is a frequent target organ of cGVHD and often the presenting location of the disease, making dermatologists key in recognition and management. It has been proposed that cutaneous cGVHD is a spectrum of disease and the lesions may evolve through various stages. Lichen sclerosus et atrophicus-like cGVHD may represent a phase in this continuum or a distinct sub-type of disease. Remaining cognizant of the potential manifestations of disease is key for prompt recognition and proper treatment.

Topics: Clobetasol; Combined Modality Therapy; Diagnosis, Differential; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Hydrocortisone; Immunosuppressive Agents; Leukemia, Promyelocytic, Acute; Lichen Sclerosus et Atrophicus; Lymphocyte Transfusion; Male; Middle Aged; Photopheresis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Tacrolimus; Triamcinolone

Topics: Administration, Topical; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Middle Aged; Tacrolimus

Topics: Administration, Topical; Chemotherapy, Adjuvant; Child; Clinical Trials, Phase II as Topic; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Prospective Studies; Tacrolimus

Lichen sclerosus is an uncommon, chronic inflammatory skin disorder of unknown origin. It is clinically characterized by sclerotic, whitish, atrophic-type lesions. The most frequent site of the lesions is generally the genital region, with about 15-20% having additional extragenital involvement. We present the case of a 62-year-old woman with a very extensive extragenital lichen sclerosus who showed great clinical and subjective improvement with 0.1% tacrolimus ointment and psoralen plus UVA (PUVA), without any topical or systemic adverse effects. Combined treatment of 0.1% tacrolimus ointment and PUVA may be a good option in extensive cases of lichen sclerosus or when other treatment options have failed, and has a good tolerability and safety profile.

Topics: Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Middle Aged; Ointments; PUVA Therapy; Tacrolimus

Lichen sclerosus (LS) is a chronic inflammatory skin condition, which most commonly causes dysuria, pruritus and soreness of the vulval and perianal areas. Potent topical corticosteroids are used for the treatment of LS, but it is well known that they inhibit collagen synthesis and cause skin atrophy as a side effect.. The present pilot study evaluated the efficacy and safety of pimecrolimus cream 1% applied twice daily for up to 6 months in 29 women with severe LS.. Of the 26 subjects who completed the follow-up period, 42% (11/26) were in complete remission with relief from itchiness, pain and inflammation. A 3.5-fold increase in type I collagen synthesis and a 7.5-fold increase in type III collagen synthesis of the affected areas was detected after 2 months of pimecrolimus treatment. There were no systemic adverse reactions, although mild local skin reactions were reported by 50% of the patients. Blood concentrations of pimecrolimus were checked in 10/26 patients (39%) and were undetectable in all cases.. Patient-applied 1% pimecrolimus cream is safe and effective for the treatment of LS.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Dermatologic Agents; Female; Humans; Lichen Sclerosus et Atrophicus; Middle Aged; Ointments; Pilot Projects; Remission Induction; Safety; Tacrolimus; Time Factors; Treatment Outcome

Topics: Aged; Condylomata Acuminata; Female; Human papillomavirus 11; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Middle Aged; Penile Diseases; Tacrolimus; Virus Activation; Vulvar Diseases; Vulvar Lichen Sclerosus

Topics: Calcineurin Inhibitors; Carcinoma, Squamous Cell; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Tacrolimus

Topics: Administration, Topical; Carcinoma, Squamous Cell; Circumcision, Male; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Male Urogenital Diseases; Penile Neoplasms; Tacrolimus

Topics: Administration, Topical; Female; Humans; Lichen Sclerosus et Atrophicus; Middle Aged; Skin Pigmentation; Stem Cell Factor; Tacrolimus

Topics: Administration, Cutaneous; Adult; Arm; Calcineurin Inhibitors; Dermatologic Agents; Diagnosis, Differential; Humans; Lichen Sclerosus et Atrophicus; Male; Peptidylprolyl Isomerase; Tacrolimus

The effective management of vulval lichen sclerosus (LS) currently depends upon the use of topical steroids and emollients. There are concerns with regard to the long-term toxicity of potent steroids and therefore is a need to consider effective alternatives. Immunomodulatory macrolactams offer an alternative to steroids in the management of some other inflammatory skin disorders and it would seem reasonable therefore to assess their activity in LS. This pilot study of 16 histologically confirmed cases of LS suggests that macrolactams have a positive pharmacological effect.

Topics: Administration, Topical; Adult; Aged; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Middle Aged; Pilot Projects; Tacrolimus; Treatment Outcome; Vulvar Diseases

Topics: Administration, Topical; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Tacrolimus; Vulvar Diseases

Topics: Biopsy, Needle; Female; Follow-Up Studies; Humans; Immunohistochemistry; Lichen Sclerosus et Atrophicus; Middle Aged; Risk Assessment; Severity of Illness Index; Tacrolimus; Treatment Outcome

Lichen sclerosus is a chronic cutaneous disorder with a predilection for the vulva. Lichen sclerosus affects more than one in 900 girls. Superpotent corticosteroids like clobetasol propionate are the most effective treatment for vulvar lichen sclerosus. However, recurrence after stopping steroids is very high. As repeated courses of corticosteroids are frequently needed, there are concerns about potential side effects. Therefore, a treatment regimen that does not rely on corticosteroids may be beneficial. As lichen sclerosus is a T-lymphocyte mediated disorder, it has been suggested that pimecrolimus, a topical T-lymphocyte inhibitor, may be safe and effective for the treatment of lichen sclerosus in children.. A 10-year-old girl with lichen sclerosus was initially treated with clobetasol. Remission was achieved, but 3 months later she had a recurrence. Subsequent treatment with clobetasol led to a breakdown of her peri-anal skin with a superimposed infection. She was then treated with pimecrolimus and remission was achieved. She has had no recurrence of active lichen sclerosus and has less burning with pimecrolimus than with clobetasol.. Pimecrolimus may be an effective treatment of vulvar lichen sclerosus. Pimecrolimus has been shown to be very safe in the pediatric population for the treatment of mild to moderate eczema, without causing dermal atrophy, tachyphylaxis, striae, rebound flares, or hypothalamic-pituitary axis suppression. As the recurrence rate of active lichen sclerosus in prepubertal girls treated with topical corticosteroids is high, and the majority of prepubertal girls with lichen sclerosus continue to have disease after menarche, a treatment regimen that does not rely on corticosteroids may be beneficial.

Topics: Administration, Cutaneous; Child; Diagnosis, Differential; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Recurrence; Tacrolimus; Vulvar Diseases

Topics: Administration, Topical; Carcinoma, Squamous Cell; Diagnosis, Differential; Female; Humans; Lichen Sclerosus et Atrophicus; Precancerous Conditions; Risk Assessment; Skin Neoplasms; Tacrolimus; Vulvar Diseases

Lichen sclerosus is a chronic inflammatory disease with a predilection of the anogenital region. Because of the potential side effects of repeated local application of potent glucocorticosteroids, equally-effective, safer therapeutic options are required, especially in the treatment of children.. We report on the efficacy of twice-daily application of pimecrolimus 1% cream in four prepubertal girls (range of age: 4 to 9 years) who suffered from anogenital lichen sclerosus. After three to four-month treatment, all patients had almost complete clinical remission including relief from itch, pain and inflammation. Only minor improvement was observed for the white sclerotic lesions. No significant side effects have been observed.. Topical pimecrolimus appears to be an effective and safe treatment for children with anogenital lichen sclerosus. The clinical benefits observed in the four patient presented particularly include relief of pruritus, pain and inflammation. Vehicle-controlled studies on a larger number of patients are now warranted to substantiate our promising findings, and to investigate long-term efficacy and safety of topical pimecrolimus in anogenital lichen sclerosus.

Topics: Administration, Cutaneous; Anus Diseases; Calcineurin Inhibitors; Child; Dermatologic Agents; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Ointments; Tacrolimus; Treatment Outcome; Vulvar Diseases

Lichen sclerosus is a chronic cutaneous disorder with a predilection for the vulva. The etiology is unknown. Superpotent topical corticosteroids are the most effective treatment. Dermal atrophy, however, is a well-known complication associated with changes of lichen sclerosus superpotent topical corticosteroids. In addition, some women do not respond adequately to topical steroids. Therefore, a treatment regimen that does not rely on corticosteroids may be beneficial. As lichen sclerosus is a T-lymphocyte-mediated disorder, it has been suggested that a topical macrolide immunosuppressant, such as pimecrolimus, may be a safe and effective alternative treatment for lichen sclerosus. Since pimecrolimus does not affect collagen synthesis, it does not cause thinning of the dermis.. Four patients with biopsy-proven lichen sclerosus were treated with 1% pimecrolimus cream twice daily. At the end of 3 months of treatment, 3 of the 4 patients reported complete resolution of their symptoms of vulvar itching and burning. Two patients had repeat vulvar biopsies at the end of treatment that showed reversal of the histologic changes of lichen sclerosus.. In this small series, pimecrolimus appeared to be a safe and effective treatment of vulvar lichen sclerosus. A randomized, controlled trial comparing pimecrolimus and clobetasol propionate should be performed to determine which is the safer and more effective medication for the long-term treatment of lichen sclerosus.

Topics: Administration, Topical; Adult; Biopsy, Needle; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Immunohistochemistry; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Middle Aged; Sampling Studies; Severity of Illness Index; Tacrolimus; Treatment Outcome; Vulvar Diseases

Lichen sclerosus most commonly affects the anogenital region. Spreading into the extragenital regions is rare, and its course is most commonly asymptomatic. Women have been reported to be affected 6 to 10 times more often than men. The etiology of lichen sclerosus is still unknown. The disease is characterized by ivory-white atrophic plaques, and no treatment ensuring complete recovery is available. T-cells are also involved in its pathogenesis. Pimecrolimus is a topical inhibitor of T-cells. In the present paper, we present a male patient with lichen sclerosus located only in extragenital regions and report an unsuccessful outcome of treatment with pimecrolimus 1% cream administered topically twice a day for 16 weeks.

Topics: Administration, Cutaneous; Aged; Back; Dermatologic Agents; Diagnosis, Differential; Humans; Lichen Sclerosus et Atrophicus; Male; Neck; Shoulder; Tacrolimus; Treatment Failure

The treatment of vulvar lichen sclerosus is generally considered difficult. Ultrapotent corticosteroids represent the most effective topical treatment, but carry the risk of side effects such as skin atrophy. We describe a 71-year-old woman with long-standing vulvar lichen sclerosus refractory to conventional treatment. After 6 consecutive weeks of treatment with tacrolimus ointment 0.1% (Protopic) twice daily, signs and symptoms of lichen sclerosus resolved. To our knowledge, this is the first report of the use of topical tacrolimus, which does not induce skin atrophy, in the treatment of vulvar lichen sclerosus.

Topics: Aged; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Ointments; Tacrolimus; Vulvar Diseases

Topics: Administration, Topical; Adult; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Ointments; Skin; Tacrolimus; Vulvar Diseases

Lichen sclerosus of the anogenital area is a chronic inflammatory and fibrosclerotic disease associated with substantial morbidity. Topical ultrapotent corticosteroids are currently the treatment of choice.. Three prepubertal girls and 3 adults (2 men, 1 woman) were treated with 0.1% tacrolimus ointment once daily. All patients experienced complete resolution with long-lasting remission for up to 1 year. No major adverse effects were observed, and treatment was well tolerated.. Topical tacrolimus is a promising novel agent in the treatment of lichen sclerosus of the anogenital area. A major advantage over topical corticosteroids is the lack of skin atrophy. Further clinical trials are warranted to confirm our findings.

Topics: Administration, Topical; Adult; Anus Diseases; Child; Child, Preschool; Female; Humans; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Middle Aged; Ointments; Penile Diseases; Tacrolimus; Vulvar Diseases

Immunomodulators include both immunostimulatory and immunosuppressive agents. Obligate contact sensitizers such as diphencyprone or dinitrochlorobenzene have been used against viral and autoimmune diseases. Newer agents such as the toll-like receptor agonists imiquimod and resiquimod have been clinically used to treat viral infections and skin cancers in immunocompetent and immunosuppressed patients. On the other hand, the topical immunosuppressive agents tacrolimus and pimecrolimus have been used with great success in the treatment of chronic inflammatory diseases in children and adults. The introduction of this new class of drugs (i.e. Calcineurin inhibitors) marked the beginning of the post-cortisone era in clinical dermatology. Toll-like receptor agonists and calcineurin antagonists will supplement corticosteroids to improve specific dermatological therapy. Topical immunotherapy with both immunostimulatory and immunosuppressive agents show potential for effective and patient-friendly treatment of inflammatory, infectious and neoplastic skin diseases. Long-term evaluation will define the tolerability and the safety profile.

Topics: Adjuvants, Immunologic; Administration, Topical; Adult; Aged; Aged, 80 and over; Aminoquinolines; Asthma; Autoimmune Diseases; Bowen's Disease; Child; Cyclopropanes; Dermatitis, Atopic; Dinitrochlorobenzene; Female; Follow-Up Studies; Herpes Simplex; Humans; Imidazoles; Imiquimod; Immunity, Cellular; Immunocompromised Host; Immunoglobulin A; Immunosuppressive Agents; Lichen Sclerosus et Atrophicus; Male; Molluscum Contagiosum; Papillomavirus Infections; Precancerous Conditions; Skin Diseases; Skin Diseases, Viral; Skin Neoplasms; Tacrolimus; Time Factors; Warts