tacrolimus and Genital-Diseases--Male

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

Genital aphthous ulcers of Behcet's disease (BD) are painful and usually resistant to local treatments. Pimecrolimus is an ascomycin macrolactam, used in inflammatory skin diseases.. To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers.. Ninety patients with genital aphthous ulcers were enrolled. Only patients treated with colchicine alone were selected. All patients signed a written consent form. Patients were randomly assigned to pimecrolimus or placebo cream, applied twice daily for 1 week. The primary outcome was the healing period. Up to 7 days, it was considered as a positive result. Results were compared by chi-square test. The mean healing time was compared by analysis of variance. Analyses were done both by the 'intention-to-treat' and 'treatment-completed' methods.. Both groups were similar at the entry (gender, age, ulcer size, pain intensity and treatment delay). By intention-to-treat analysis, in the pimecrolimus group, 18 patients had positive and 27 negative results. In the control group, four had positive and 41 negative results. The difference was significant (chi(2) = 10.167, P = 0.001). By treatment-completed analysis, with pimecrolimus, 18 patients had positive and 22 negative results. With placebo, four had positive, and 41 negative results. The difference was significant (chi(2) = 12.574, P = 0.0004). Comparison of mean healing time in the pimecrolimus versus placebo group, demonstrated a significant acceleration both in intention-to-treat analysis (10.7 vs. 20.7 days, F = 17.466, P < 0.0001) and treatment-completed analysis (8.3 vs. 20.7 days, F = 29.289, P < 0.0001).. Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process.

Topics: Administration, Cutaneous; Adolescent; Adult; Behcet Syndrome; Chi-Square Distribution; Dermatologic Agents; Double-Blind Method; Female; Genital Diseases, Female; Genital Diseases, Male; Humans; Iran; Male; Middle Aged; Placebo Effect; Stomatitis, Aphthous; Tacrolimus; Time Factors; Treatment Outcome; Wound Healing; Young Adult

Recurrent and painful genital ulcers are the hallmark of Behçet's disease.. To determine the efficacy of pimecrolimus (PIM) cream on the pain and healing time of genital ulcers.. A total of 76 patients were randomized to either receive PIM cream plus colchicine (COL) tablets (1-2 g/day) or COL tablets (1-2 g/day) alone for 1 month. Clinical evaluations were performed in 68 patients at the baseline and on the 3rd, 7th, 10th, 14th and 28th days of treatment. Also, genital ulcer pain was evaluated using a verbal pain score at each visit. Safety was monitored through adverse event reporting and laboratory tests.. The mean healing time of genital ulcers was shorter in the PIM + COL group (4.2 +/- 1.5 days) than the COL group (4.7 +/- 1.8 days), without statistical significance (p = 0.399). Visual analog scale scores decreased in both groups significantly. Neither of the treatment modalities was found to be superior to the other; however, pain was relieved in 4.2 +/- 0.5 days in PIM + COL group and in 5.5 +/- 1.2 days in COL group in the intention to treat population (p = 0.023). Observed adverse events were transient.. Compared to COL alone, COL + PIM cream shortens the pain duration without any significant effect on healing time.

Topics: Adult; Behcet Syndrome; Colchicine; Dermatologic Agents; Drug Therapy, Combination; Emollients; Female; Genital Diseases, Female; Genital Diseases, Male; Humans; Male; Pain; Pain Measurement; Retrospective Studies; Scrotum; Tablets; Tacrolimus; Treatment Outcome; Turkey; Ulcer; Vagina

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

Tacrolimus is an immunomodulatory agent that inhibits the activation and maturation of T-cells and blocks transcriptional activation of several cytokine genes. It also interferes with the function of Langerhans cells, basophil cells and mast cells. Recent studies have demonstrated the efficacy of topical tacrolimus in inflammatory skin disorders. Our objective was to assess the efficacy of topical treatment with tacrolimus ointment 0.1% in patients with psoriasis on the anogenital region and the face. Included in the study were 10 patients with a long-standing history of genital and facial psoriasis, partially controlled with periodic use of topical corticosteroids. Tacrolimus ointment 0.1% was applied twice daily for 10 days. The patients were followed-up every 3 weeks for a total period of 12 weeks. The severity of psoriasis was evaluated in all patients at baseline (day 0) and at the end of weeks 3, 6, 9 and 12. Clinical severity of erythema, scaling, infiltration and lesional extent were graded using a 0-3 scale indicating none, mild, moderate and severe expression, at baseline and at follow-ups. An overall severity score of 0 (clear), 1-4 (mild), 5-8 (moderate) or 9-12 (severe) was then assigned to each patient by adding the scores for the above parameters. On each visit, every patient was evaluated clinically. The decision to reapply the drug was determined by the clinical response of each patient at each visit. At the end of the study, patients also assessed efficacy, safety and tolerance after topical application of tacrolimus ointment using a 0-5 scale for each parameter: A marked improvement was noticed in all patients at the end of the first week without drug-related adverse effects. There were 15 recurrences during the 12-week period in all patients. In conclusion, tacrolimus ointment 0.1% seems to represent a safe new option for the treatment of genital and facial psoriasis. Further studies are probably needed to specify the therapeutic dosage and maintenance therapy

Topics: Adult; Face; Female; Genital Diseases, Male; Humans; Immunosuppressive Agents; Male; Psoriasis; Tacrolimus

Topics: Acantholysis; Aged; Dermatologic Agents; Genital Diseases, Male; Humans; Keratinocytes; Keratosis; Male; Scrotum; 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

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

Topics: Administration, Topical; Aged; Antipruritics; Female; Genital Diseases, Male; Humans; Immunosuppressive Agents; Male; Pruritus; Pruritus Vulvae; Scrotum; Tacrolimus

The ulcerative variant of lichen planus (LP) commonly involves the oral mucosa but is uncommon and difficult to treat when located on other areas. We describe an unusual case of ulcerative LP involving several surfaces, including the palms and scrotum, in a 50-year-old man with hepatitis C. The patient was recalcitrant to treatment with conventional therapy but obtained clearance with a sustained response using low molecular weight heparin (LMWH). This treatment is an option for patients with LP who are not ideal candidates for standard therapy.

Topics: Anti-Inflammatory Agents; Anticoagulants; Clobetasol; Genital Diseases, Male; Hand Dermatoses; Heparin, Low-Molecular-Weight; Hepatitis C; Humans; Immunosuppressive Agents; Lichen Planus; Male; Middle Aged; Scrotum; Skin Ulcer; Tacrolimus