An open-label pilot study to evaluate the safety and efficacy of topically applied pimecrolimus cream for the treatment of steroid-induced rosacea-like eruption

BACKGROUND: Steroid-induced rosacea-like eruption is characterized by facial rosacea-like dermatitis in patients that have been treated with topical steroids for relatively long periods. OBJECTIVE: To evaluate the efficacy and tolerability of 1% pimecrolimus topical cream for steroid-induced rosacea-like eruption. METHODS: In an open-label pilot study, 40 patients were enrolled and instructed to apply 1% pimecrolimus cream twice daily for 6 weeks. Patients were evaluated by a rosacea clinical score, investigator's global assessment, overall erythema severity, and tolerability at weeks 0, 2, and 6. RESULTS: In 35 patients, the rosacea clinical score decreased significantly from 16.0+/-4.3 at baseline to 8.1+/-3.3 at week 2 and 4.2+/-2.5 at week 6 (P<0.0001). Investigator's global assessment was 4.1+/-1.1 (baseline), then decreased to 1.4+/-0.8 (week 2) and 0.5+/-0.6 (week 6) (P<0.0001). By week 6, 48.6% of the patients were clear. Overall erythema severity was 2.4+/-0.7 (baseline), 0.9+/-0.4 (week 2), and 0.3+/-0.4 (week 6) (P<0.0001). Cutaneous adverse events (local burning, stinging, and itching) occurred in 17.5%. CONCLUSION: Pimecrolimus cream might be efficacious, safe, and well tolerated for steroid-induced rosacea-like eruption. The small sample size and open label nature of this study is its limitation. Further double-blind, vehicle-controlled studies are needed.     

An open-label efficacy pilot study with pimecrolimus cream 1% in adults with facial seborrhoeic dermatitis infected with HIV

BACKGROUND: Seborrhoeic dermatitis (SD) is a common dermatosis in human immunodeficiency virus (HIV)-positive patients, many of whom do not respond satisfactorily to conventional topical treatments such as corticosteroids and antifungals. OBJECTIVE: A pilot study to investigate the efficacy and tolerability of pimecrolimus cream 1% in HIV-positive patients with facial SD. METHODS: In a single-centre study, 21 HIV-infected patients with mild to severe SD were treated twice daily with pimecrolimus cream 1% for 14 days. Thereafter, treatment was discontinued and patients followed up for 5 weeks. Skin involvement at baseline and on days 7, 14, 21, 35 and 49 was assessed using a four-point clinical score and digital photography. MAIN OUTCOME MEASURES: Efficacy and safety of pimecrolimus cream 1% treatment and incidence of relapse in the follow-up phase. Results Marked improvement was seen in clinical parameters at day 7, with >or= 90% patients clear of symptoms at day 14. Relapse was observed at day 35 but signs were milder than at baseline. All patients responded to therapy, despite their immunological status. Pimecrolimus did not alter CD4(+) and CD8(+) T-cell counts or viral load during the treatment period. CONCLUSION: Pimecrolimus cream represents a new, effective therapeutic option for facial SD in HIV patients.     

吡美莫司乳膏联合盐酸小檗碱溶液湿敷治疗酒渣鼻疗效观察

目的:评价吡美莫司乳膏联合盐酸小檗碱溶液湿敷治疗酒渣鼻的临床疗效。方法:入选的42例酒渣鼻患者均外用1%吡美莫司软膏联合3%盐酸小檗碱溶液湿敷,2次/天,共4周。于治疗前及治疗后第1、2、3和4周时各随访1次。结果:42例患者中33例完成临床实验,治疗后第1、2、3和4周时,丘疹脓疱型酒渣鼻有效率分别为12.12%、18.18%、27.27%和36.36%,红斑型有效率分别为42.42%、57.56%、69.70%和78.79%。吡美莫司软膏联合盐酸小檗碱溶液湿敷对表现为红斑型酒渣鼻患者的疗效优于丘疹、脓疱型。在治疗3~5天时,21.43%的患者出现局部刺激反应。结论:吡美莫司乳膏联合盐酸小檗碱溶液湿敷治疗酒渣鼻安全、有效,对以红斑为主要临床表现的酒渣鼻患者疗效较好。     

浆细胞性龟头炎一例并文献复习

本文报道1例浆细胞性龟头炎患者并回顾相关文献。患者,男,65岁。龟头红斑2年,皮疹表现为龟头两处境界清楚呈花瓣型鲜红色斑片,表面湿润,触诊无压痛,无明显溃疡,无明显浸润感。皮肤组织病理检示：表皮萎缩,部分真表皮分离,真皮浅层大量淋巴细胞、浆细胞浸润。诊断:浆细胞性龟头炎。治疗：外用1%吡美莫司乳膏,3个月后皮疹好转,现正随访中。     

Atopic dermatitis: review of immunopathogenesis and advances in immunosuppressive therapy

This paper reviews the theories of the pathogenesis of atopic dermatitis (AD), with a particular emphasis on its immunopathogenesis. The contribution of predisposing factors, immunopathogenic factors and provoking factors in the pathogenesis of AD are considered. Predisposing factors explored in this article include genetics and the disturbance of skin function. Immunopathogenic factors reviewed include T cell dysfunction, biphasic cytokine expression and the role of immunoglobulin E. Provoking factors considered include microbial factors, psychosomatic interactions, contact allergens and irritants, inhalant allergens, food and climate. Immunosuppressive treatments reviewed include cyclosporin, azathioprine, methotrexate, tacrolimus, interferon-gamma, phosphodiesterase inhibitors and pimecrolimus (SDZ ASM 981).     

Managing childhood atopic dermatitis

Atopic dermatitis, a chronic inflammatory skin disorder that affects up to 20% of school-aged children, can profoundly influence quality of life. Basic therapy consists of avoidance of triggering factors and optimal skin care. Until now, corticosteroids have been the usual treatment for acute flares. Short-term safety profiles are reasonable, but long-term use of corticosteroids may involve significant adverse effects. Topical immunomodulators (tacrolimus and pimecrolimus) are beneficial and safe for adults and children and represent a major new alternative to chronic cortico-steroid use, especially in children.     

Two cases of telangiectasia macularis eruptiva perstans demonstrated by immunohistochemistry for c-kit (CD 117)

Telangiectasia macularis eruptiva perstans (TMEP) is an uncommon form of cutaneous mastocytosis that occurs exclusively in adults. Histologically, TMEP presents with scattered mast cells lined up around the dilated capillaries and venules of the superficial vascular plexus. In some cases, the number of mast cells falls within the range observed in normal skin and therefore cannot be detected by routine histologic examination. We used immunohistochemical staining for c-kit (CD 117) for the definitive diagnosis in two patients with TMEP. One of them was successfully treated with topical application of pimecrolimus.     

Clinical behaviour and long‐term therapeutic response in orofacial granulomatosis patients treated with intralesional triamcinolone acetonide injections alone or in combination with topical pimecrolimus 1%

Background: Orofacial granulomatosis (OFG) is a relapsing inflammatory disorder of unknown aetiology and non‐standardized treatment protocols. The aim of this study was to assess the clinical behaviour and long‐term therapeutic response in OFG patients treated with intralesional triamcinolone acetonide (TA) injections alone or in combination with topical pimecrolimus 1%, as adjuvant, in those patients partially responders to TA. Methods: We analysed data from 19 OFG patients followed‐up for 7 years. Demographic characteristics, clinical behaviour and long‐term therapeutic response were investigated. Results: Eleven (57.9%) OFG patients treated with intralesional TA injections therapy reached first complete clinical remission in a mean time of 10 ± 2.2 (95% CI, 8.5–11.5) weeks, while eight (42.1%) patients, partially responders to intralesional TA injections, were treated with TA injections plus topical pimecrolimus 1%, as adjuvant, achieving complete clinical remission in a mean time of 29.8 ± 7.8 (95% CI, 23.2–36.3) weeks. Relapses occurred in four TA responder patients with a disease‐free time of 35.8 ± 8.7 (95% CI, 21.9–46.4) weeks and in five patients treated with TA and topical pimecrolimus 1% with a disease‐free time of 55.8 ± 18.5 (95% CI, 32.8–78.8) weeks. Patients were followed‐up for a mean time of 56.3 ± 18.2 (95% CI, 47.6–65.1) months. At last control, all 19 patients were in complete clinical remission. Conclusion: These preliminary data suggest that intralesional TA injections still represent a mainstay in the treatment of OFG. It is unclear the role of topical pimecrolimus, as adjuvant, in leading OFG patients, partly responders to intralesional TA injections, to a complete clinical remission.     

吡美莫司乳膏联合强脉冲光治疗面部糖皮质激素依赖性皮炎疗效观察

目的：观察外用吡美莫司乳膏联合强脉冲光治疗面部糖皮质激素依赖性皮炎的临床疗效和安全性。方法：给予34例面部糖皮质激素依赖性皮炎患者外用1％吡美莫司乳膏,每日1次,共4周。结束2周后,采用强脉冲光进行4次治疗,每次间隔3周。于治疗前、外用药物4周后及4次强脉冲光治疗结束后3周时各随访1次。结果：34例患者中28例完成临床试验。外用药治疗4周时及联合4次强脉冲光结束后3周时临床显效率分别为39．3％、53．6％,外用药治疗中10．7％的患者局部有一过性刺激反应。患者的红斑丘疹、脱屑性皮疹改变较好;联合强脉冲光治疗后可进一步改善患者色素沉着和毛细血管扩张等症状,从而提高疗效,且无不良反应。结论：外用吡美莫司乳膏联合强脉冲光治疗面部激素依赖性皮炎安全、有效。