Lymecycline and minocycline in inflammatory acne: a randomized, double-blind intent-to-treat study on clinical and in vivo antibacterial efficacy

BACKGROUND: Some antibiotics represent a mainstay in acne treatment. However, studies comparing their efficacies are rare. AIM: To evaluate the clinical and in vivo antibacterial effect of lymecycline and minocycline at different dosages. METHOD: Eighty-six patients with moderate to severe acne were enrolled in a randomized, double-blind, intent-to-treat study comparing in three parallel groups the effect of (1) lymecycline 300 mg daily for 12 weeks, (2) minocycline 50 mg daily for 12 weeks and (3) minocycline 100 mg daily for 4 weeks followed by 50 mg daily for 8 weeks. Evaluations were made at the screening visit and at five on-treatment visits. They consisted of clinical counts of acne lesions and evaluations of bacterial viability using dual flow cytometry performed on microorganisms collected from sebaceous infundibula by cyanoacrylate strippings. RESULTS: Patients receiving minocycline 100/50 mg had the best clinical outcome, particularly in the reduction of the number of papules. By the end of the trial, the microbial response to minocycline 100/ 50 mg was also superior to either of the other two treatments. There were less live and more dead bacteria. CONCLUSION: In this trial, minocycline 100/50 mg was superior for the treatment of inflammatory acne when compared to lymecycline 300 mg and minocycline 50 mg.     

Tazarotene versus tazarotene plus hydroquinone in the treatment of photodamaged facial skin: a multicenter, double-blind, randomized study.

OBJECTIVES: To compare the efficacy and tolerability of tazarotene plus hydroquinone versus tazarotene alone in the treatment of facial photodamage. METHODS: Patients with facial mottled hyperpigmentation of at least moderate severity and an overall integrated assessment of photodamage score of at least moderate applied tazarotene 0.1% cream each evening and either hydroquinone 4% cream or placebo cream each morning for up to 24 weeks. RESULTS: Among 131 patients enrolled, 114/124 (92%) with exit data completed. Both regimens were highly effective in reducing photodamage, with tazarotene plus hydroquinone showing superiority over tazarotene alone for some efficacy measures. The incidence of >or=1-grade improvement from baseline (on a scale of none, minimal, mild, moderate, or severe) was significantly greater with tazarotene plus hydroquinone than with tazarotene alone for lentigines (weeks 12-24, por=50% global improvement was also significantly superior with the combination regimen as early as week 8 (p相似文献   

Tazarotene cream for postinflammatory hyperpigmentation and acne vulgaris in darker skin: a double-blind, randomized, vehicle-controlled study

Previous investigations have reported the efficacy of tazarotene 0.1% cream for the treatment of dyschromia associated with photoaging and for acne vulgaris. The present investigation assessed tazarotene 0.1% cream for the treatment of postinflammatory hyperpigmentation (PIH) in a double-blind, randomized, vehicle-controlled study of 74 patients from darker racial ethnic groups who had acne. Once-daily application of tazarotene cream was shown to be effective against PIH, achieving significantly greater reductions compared with vehicle in overall disease severity and in the intensity and area of hyperpigmentation within 18 weeks (P< or =.05). Mean levels of erythema, burning, and peeling were no more than trace in both groups throughout the study, and mean levels of dryness were no more than mild in both groups. In our study, tazarotene cream was effective and well tolerated in the treatment of PIH in patients with darker skin.     

Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.

Retinoids reverse the abnormal pattern of keratinization seen in acne vulgaris. Tazarotene is the first of a novel family of topical receptor-selective acetylenic retinoids. This study evaluates the safety and efficacy of topical tazarotene 0.1% and 0.05% gels, in comparison to vehicle gel, applied once daily for 12 weeks, in the treatment of mild-to-moderate facial acne vulgaris. A total of 446 patients with facial acne vulgaris were enrolled, and 375 patients, ranging in age from 14 to 44 years, were evaluable in this multicenter, double-blind, randomized study. In comparison to vehicle gel, treatment with tazarotene 0.1% gel resulted in significantly greater reductions in noninflammatory and total lesion counts at all follow-up visits, and inflammatory lesion counts at Week 12. Tazarotene 0.05% gel resulted in significantly greater reductions in noninflammatory and total lesion counts than vehicle gel at Weeks 8 and 12. At Week 12, treatment success rates were 68% and 51% for tazarotene 0.1% and 0.05%, respectively (40% for vehicle gel). Tazarotene gel was an effective, safe, and generally well-tolerated therapy for the treatment of acne vulgaris.     

异维A酸红霉素凝胶治疗寻常痤疮的多中心随机对照临床研究

目的 比较异维A酸红霉素凝胶与阿达帕林凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 多中心、开放、随机、平行对照研究。按照中国痤疮治疗指南痤疮严重程度标准入选轻、中度（Ⅰ ~ Ⅲ级）寻常痤疮患者192例,纳入疗效分析169例,安全性分析190例。试验组86例,外用异维A酸红霉素凝胶;对照组83例,外用阿达帕林凝胶,均为每晚1次,共用药6周。在基线、治疗2、4和6周时分别记录患者白头粉刺、黑头粉刺、炎性丘疹、脓疱数,评价各时间点患者痤疮严重程度,同时记录皮肤局部耐受性以及其他不良反应。结果 随着治疗时间延长,两组的有效率逐渐提高,总体病情严重程度改善。在治疗6周时,试验组总有效率为51.16%,对照组为40.96%,两组差异无统计学意义（P > 0.05）;但在治疗4周及6周时,试验组患者脓疱及炎性皮损的疗效优于对照组（P < 0.05）,同时试验组痤疮分级较对照组低（P < 0.01）。两组不良反应类似,均表现为局部刺激,可耐受。结论 异维A酸红霉素凝胶治疗轻、中度寻常痤疮总有效率与阿达帕林凝胶类似,对于炎性损害疗效优于阿达帕林凝胶,并且对患者总体严重程度降低更快。     

富马酸氯马斯汀注射液治疗急性荨麻疹多中心随机双盲对照研究

目的 评价富马酸氯马斯汀注射液治疗急性荨麻疹的有效性和安全性。 方法 选择急性荨麻疹患者为研究对象,采用多中心随机双盲研究设计,试验组肌内注射富马酸氯马斯汀注射液（2 mg/次）,对照组肌内注射马来酸氯苯那敏注射液（10 mg/次）,均每12 h 1次,共2次,观察24 h。评价疗前及疗后症状体征总积分、各时间点总有效率、各症状体征改善率和基本缓解率,观察不良反应。 结果 入组144例患者,试验组和对照组各72例,138例纳入疗效分析。试验组有效率为78.87％（56/71）,对照组有效率为77.61％（52/67）,两组比较差异无统计学意义（χ2 = 0.02,P > 0.05）;首次注射后1 h,两组瘙痒、风团大小和数量及风团水肿程度改善率差异均无统计学意义（均P > 0.05）;两组各症状体征的基本缓解率在各时间点比较差异均无统计学意义（均P > 0.05）。两组常见的不良反应有嗜睡、口干、头痛、头晕等,其中试验组嗜睡的发生率为11.11%（8/72）,对照组为20.14%（15/72）,差异有统计学意义（χ2 = 4.451,P < 0.05）。 结论 富马酸氯马斯汀注射液可有效控制急性荨麻疹症状,且其嗜睡的发生率低于马来酸氯苯那敏。     

Efficacy of oral antibiotics on acne vulgaris and their effects on quality of life: a multicenter randomized controlled trial using minocycline, roxithromycin and faropenem

There are few clinical studies which compare the efficacy and patient satisfaction for oral antibiotics to treat inflammatory acne. To clarify the difference between oral antibiotics, acne patients with moderate to severe inflammatory eruptions were randomized into three groups, and each patient was given minocycline (MINO), roxithromycin (RXM) or faropenem (FRPM) for 4 weeks, followed by 4 weeks of observation without any oral antibiotics. We estimated the reduction rate of inflammatory lesion counts, the scale of Skindex-16 which represents patient quality of life (QOL), and minimum inhibitory concentrations required to inhibit the growth of 90% of Propionibacterium acnes isolated from acne patients (MIC(90) ). In all three groups, inflammatory lesion counts, and emotional and total score of Skindex-16 were significantly improved (P<0.05) after 4 weeks treatment, and these effects were maintained for the following 4 weeks. Dizziness/nausea in two patients (4.1%) of the MINO group and diarrhea in three patients (5.9%) of the FRPM group were observed. There was no significant difference of percentage reduction in inflammatory lesion counts and incident rates of side-effects between these three oral antibiotics. MIC(90) of MINO was 0.25 μg/mL before and after treatment, but MIC(90) of RXM had increased from 0.25 μg/mL to more than 32 μg/mL after treatment. MIC(90) of FRPM was 0.06 μg/mL or less for all strains before and after treatment. Our randomized controlled clinical trial suggested that MINO, RXM and FRPM were efficient to improve inflammatory acne and patient QOL, and there was no significant difference between them.     

Topical tazarotene therapy for psoriasis,acne vulgaris,and photoaging

Psoriasis, acne vulgaris and photoaging are common conditions. Tazarotene is a pro-drug of tazarotenic acid, a receptor-selective retinoid, which has shown efficacy in the treatment of these disorders. In the treatment of acne vulgaris, it has greater comedolytic activity than the currently available topical retinoids. In psoriasis, tazarotene normalizes keratinocyte differentiation, reverses keratinocyte hyperproliferation and has better anti-inflammatory effects than any of the currently available topical retinoids. It is most commonly used as combination therapy with a topical corticosteroid or phototherapy in psoriasis, or with an antibiotic in acne.     

A double-blind comparison of topical clindamycin and oral minocycline in the treatment of acne vulgaris

Sixty-six patients with moderate to severe facial acne vulgaris were entered in a 12-week double-blind study to compare the efficacy of topical clindamycin phosphate 1% twice daily and oral minocycline 50 mg twice daily. Both treatments gave significant overall improvements from baseline observations in acne grade and inflamed lesion counts, but not in noninflamed lesion counts. There were no significant differences between the two treatment groups in respect of acne grade, inflamed or non-inflamed lesion counts. Both treatment regimes were well tolerated. This study has shown that topical clindamycin twice daily is an effective alternative to oral minocycline 50 mg twice daily in the treatment of moderate to severe facial acne vulgaris.     

A double-blinded, randomized, vehicle-controlled, multicenter, parallel-group study to assess the safety and efficacy of tretinoin gel microsphere 0.04% in the treatment of acne vulgaris in adults

This double-blinded, randomized, vehicle-controlled, multicenter, parallel-group, 12-week, phase 4 study was conducted in adults with mild to moderate acne vulgaris. Of 178 subjects randomized to be treated, 88 subjects (49%) were treated with tretinoin gel microsphere 0.04% and 90 subjects (51%) were treated with vehicle. Inflammatory lesion counts were statistically significantly reduced at 2 weeks in tretinoin-treated subjects (P = .0110), and reductions in total lesion counts also were noted. The reduction in total lesion counts reached statistical significance at week 4 (P = .0305); at week 12, mean total, inflammatory, and noninflammatory lesion counts were statistically significantly lower in the tretinoin treatment group versus vehicle group (P < .05), and mean percentage reductions in lesion counts were significantly greater in the subjects with noninflammatory lesions treated with tretinoin compared with vehicle (P < .05). Mean percentage reductions in total, inflammatory, and noninflammatory lesion counts were 35.5%, 38.2%, and 33.6%, respectively, at week 12 for the tretinoin treatment group compared with 20.9%, 19.2%, and 20.4%, respectively, for the vehicle group (all P < .05). All adverse events were of mild or moderate intensity with the exception of severe skin irritation in one tretinoin-treated subject. At week 12, there were no statistically significant differences between treatment groups for any measured tolerability parameter.     

维胺酯和异维A酸治疗寻常痤疮随机双盲研究

目的 评价维胺酯胶囊和异维A酸胶丸治疗中重度寻常痤疮的疗效和安全性.方法 采用多中心、随机、双肓双模拟、对照临床研究,按痤疮综合分析系统(GAGS)评价痤疮的严重程度,将评分确定为中重度痤疮的患者随机分为维胺酯组(50mg,每日3次)和异维A酸组(10mg,每日2次),于服药前、服药后2、4、6周计数皮损,观察疗效和不良反应.结果 共入组227例,计入全分析集(FAS)分析213例,符合方案集(PPS)分析200例.PPS分析治疗后2、4、6周异维A酸组有效率分别为6.0%、29.0%、57.0%;维胺酯组分别为5.0%、20.0%、51.00%,两组比较差异无统计学意义(P>0.05).各随访期皮损数下降值比较,除异维A酸组炎性丘疹和脓疱数下降值高于维胺酯组(P<0.05)外,粉刺、结节类皮损数两组差异无统计学意义.FAS分析不良反应发生率异维A酸组(68.81%)显著高于维胺酯组(36.53%)(P<0.001),常见不良反应如口干、口唇脱屑异维A酸组发生率显著高于维胺酯组(P<0.001),不良反应的程度也明显重于维胺酯组(P<0.05).结论 异维A酸和维胺酯治疗中重度痤疮疗效较为一致,但异维A酸治疗炎性皮疹起效较快,同时其常见不良反应也多于维胺酯.     

A multicenter epidemiological study of acne vulgaris in Korea

Background Acne is a common skin disorder that affects both adolescents and adults. However, few epidemiological studies on this condition have been conducted in Asia. Objectives The purpose of this study was to analyze the incidence of acne and to identify its demographic and clinical features and aggravating factors. In addition, we examined the relationships between these factors. Methods Epidemiological and clinical data were obtained, using a self‐administered questionnaire, from patients who visited 17 general hospitals and from the consulting dermatologists. Results A total of 1236 patients were involved in this study. Acne first developed and presented most commonly on the forehead and cheeks, although the cheeks were more severely affected. Significant associations were found between the clinical, epidemiological, and behavioral characteristics of acne patients according to several factors, such as sex, age at onset, previous treatment history, and family history. The present study indicates that stress, lack of sleep, smoking, alcohol consumption, and menstruation aggravate acne. Conclusions This study presents the demographic features and clinical characteristics of acne sufferers in Korea. This large‐scale analysis provides a useful overview of acne in Korea.     

盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病的多中心临床研究

目的:评价盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病的疗效和安全性.方法:本试验为随机、双盲、多中心临床研究.入选患者分别接受盐酸左氧氟沙星凝胶或氧氟沙星凝胶治疗,每日2次,共7天.在治疗时及治疗后第4天和治疗后评价临床和细菌学疗效.结果:共入选受试者222例,脱落5例,剔除2例,治疗后第4天和治疗后各项症状/体征指标记分及总记分均有明显下降.试验组和对照组组间比较差异无统计学意义.用药4天和7天后,试验组基愈率分别为0.93%和50.93%,有效率分别为35.19%、88.89%;对照组基愈率分别为0.93%和40.93%,有效率分别为25.23%和88.79%.病原体的清除率分别为85.19%和78.48%.研究中两组均无严重不良反应发生,试验组不良反应发生率为2.70%(3/111),对照组不良反应发生率为4.50%(5/111).结论:盐酸左氧氟沙星凝胶治疗细菌感染性皮肤病疗效确切、安全性好.     

他扎罗汀乳膏治疗寻常痤疮疗效观察

2007年1-6月,我们使用0.1%他扎罗汀乳膏治疗寻常痤疮,评价其疗效与不良反应. 一、病例与方法 1.临床资料:入选患者均来自本科门诊,按痤疮国际分类法临床确诊为Ⅰ级～Ⅱ级痤疮[1].共收集患者150例,采用随机数字表法将患者分为治疗组和对照组,失访6例,完成观察者144例,其中治疗组74例,男35例,女39例;年龄15～35岁,病程3个月至lO年;对照组70例,男32例,女38例,年龄14～35岁,病程1个月至10年,均无全身性疾病,治疗前1个月内未用过任何治疗痤疮的药物,治疗期间停用其他药物.     

Treatment of acne with intermittent and conventional isotretinoin: a randomized,controlled multicenter study

Oral isotretinoin is the most effective choice in the treatment of severe acne. Application of isotretionin to acne has been expanded to treat those patients with less severe but scarring acne who are responding unsatisfactorily to conventional therapies. However, its use is associated with many side effects, some of which can result in very disastrous consequences. Data related with intermittent isotretinoin therapy is still limited. Our aim was to asses the efficacy and tolerability of two different intermittent isotretinoin courses and compare them with conventional isotretinoin treatment. In this multicenter and controlled study, 66 patients with moderate to severe cases were randomized to receive either isotretionin for the first 10 days of each month for 6 months (group 1), or each day in the first month, afterwards the first 10 days of each month for 5 months (group 2) or daily for 6 months (group 3). The drug dosage was 0.5 mg/kg/day in all groups. Patients were followed-up for 12 months. Efficacy values were evaluable for 22 patients in group 1, 19 patients in group 2, and 19 patients in group 3. Acne scores in each group were significantly lower at the end of treatment and follow-up periods (P < 0.001). When patients were evaluated separately as moderate (n = 31) and severe (n = 29), no statistically significant differences were obtained among the treatment protocols in patients with moderate acne. However, there was a significant difference between groups 1 and 3 to the response of the treatments in severe acne patients at the end of follow-up period (P = 0.013). The frequency and severity of isotretionin-related side effects were found to be lower in groups 1 and 2 compared with group 3. Intermittent isotretinoin may represent an effective alternative treatment, especially in moderate acne with a low incidence and severity of side effects. The intermittent isotretinoin can be recommended in those patients not tolerating the classical dosage.     

他扎罗汀乳膏短时接触疗法治疗寻常痤疮的临床研究

目的 评价0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮时能否有效减轻局部不良反应,以及对临床疗效和症状反复的影响.方法 多中心、随机对照方法,将纳入观察的187例寻常痤疮病例分为短时接触疗法8周组,短时接触疗法12周组和常规治疗组.按Doshi痤疮综合分级系统(GAGS)计分评价,观察在治疗开始前(基线期)、完成时以及完成后的第2、4、8周内症状变化情况,评估局部不良反应和疗效,以及对病情反复的影响.结果 短时接触疗法8周组、12周组和常规治疗组局部不良反应率分别为11.48%、12.90%和38.33%,三组比较,差异有统计学意义(X2=13.31,P<0.01).短时接触疗法12周组总有效率(80.65%)较8周组(63.93%)高(X2=3.84,P<0.05).三组总有效率比较,差异无统计学意义(X2=1.98,P>0.05).短时接触疗法12周组能明显降低病情反复,三组间2,4、8周各随访段病情反复率比较,差异均有统计学意义(X2=3.29,3.78和5.85,P<0.05或P<0.01).结论 0.1%他扎罗汀乳膏短时接触疗法治疗寻常痤疮能有效减轻局部不良反应,且不降低疗效;而延长短时接触疗法疗程能减少症状反复,提高疗效.