Stanozolol in chronic urticaria: a double blind, placebo controlled trial

H1-type antihistamine drugs are mainstays in the management of chronic urticaria. For patients with refractory, chronic, idiopathic urticaria who have failed to benefit from conventional therapy, other safe therapeutic modalities are required. To evaluate the role of stanozolol as an adjunctive therapeutic agent with H1-antihistamine in refractory chronic idiopathic urticaria, we conducted this study. Fifty-eight patients with chronic refractory urticaria were enrolled in this trial and were randomly assigned to two groups (A and B). Patients in group A received 2 mg stanozolol twice daily along with cetrizine 10 mg daily. Patients in group B received cetrizine 10 mg daily and placebo tablets twice daily. The improvement was monitored by estimation of severity score. Of the 58 patients, 26 in group A and 24 in group B could be evaluated. At the end of 12 weeks, 17 patients in group A showed marked to complete resolution as compared to 7 patients in group B (chi-square p<0.01). The intention to treat analysis p value was a found to be <0.007. There was a highly significant decrease in mean severity score at 12 weeks (p<0.001) in group A patients. The present study demonstrated that stanozolol is an effective and safe adjuvant therapy for treatment of chronic refractory urticaria.     

Effect of combination therapy with systemic glucantime and pentoxifylline in the treatment of cutaneous leishmaniasis

INTRODUCTION: Cutaneous leishmaniasis is a common parasitic disease in Iran, especially in Isfahan. First line treatment for this disease is antimonial compounds; however, owing to the intermittent failure of this treatment and its significant side-effects alternative therapeutic measures have been advocated. OBJECTIVE: Evaluating the efficacy of pentoxifylline plus glucantime in the treatment of cutaneous leishmaniasis. METHODS: This double-blind, randomized, controlled clinical trial with simple sampling was performed on 64 patients with cutaneous leishmaniasis referred to the Skin Diseases & Leishmaniasis Research Center from an endemic foci of L. major in Isfahan. The patients randomly were divided into two groups. One group was treated with systemic Glucantime (20 mg pentavalent antimony/kg/day) combined with pentoxifylline (400 mg three times daily) and the other group were treated with Glucantime (20 mg pentavalent antimony/kg/day) plus placebo (three tablets daily) for 20 days. Follow up lasted 3 months. Response to treatment was grouped as complete improvement (lesions had been flattened, no induration, and epidermal creases had appeared), partial improvement (reduction in lesion size, but without the appearance of epidermal creases) and poor response (no reduction in lesion size). RESULTS: Of 64 participants, 32 patients in the trial group and 31 patients in the control group were followed for 3 months. One patient in group B discontinued withdrew. After this time, complete improvement, partial improvement and poor response to treatment were 81.3%, 12.5% and 6.2% in the trial group and 51.6%, 29% and 19.4% in the control group, respectively. We also observed no adverse effect resulting from pentoxifylline. DISCUSSION: The result obtained by two therapeutic methods indicates that combined therapy with Glucantime and pentoxifylline is more effective than Glucantime alone (P < 0.05).     

Treatment of head and neck dermatitis comparing itraconazole 200 mg and 400 mg daily for 1 week with placebo

BACKGROUND: Head and neck dermatitis (HND) is a variant of atopic dermatitis often seen in young adults. A hypersensitivity to Malassezi antigens is considered to be of pathogenic importance. Previous mostly uncontrolled studies have shown that oral antimycotics might be of use in this condition. OBJECTIVE: To evaluate the efficacy of itraconazole in the treatment of HND in a randomized, double-blind, placebo-controlled trial. PATIENTS: Adult patients with HND were included. Systemic steroids and oral/topical antimycotics were avoided 1 and 2 months prior to the trial. Topical steroids were not allowed in the head and neck area within 2 weeks. Patients in generally good health were included and female patients had to have had a negative urine pregnancy test. The patients signed an informed consent. STUDY DESIGN: The study included a 7-day treatment period and a follow-up period of 105 days. Control visits were carried out on days 3, 7 and 14 and after 15 weeks. METHODS: The SCORAD index (one for the head and neck area and one for the remaining surface area) and global evaluations by patient and investigator were used for clinical evaluation at each visit. Prick tests with Malassezia antigens and Candida albicans antigen were carried out at the start of the trial and included positive and negative controls. The patients were randomized into three groups, which were treated with 400 mg itraconazole daily, 200 mg itraconazole daily or placebo, respectively, for 7 days. RESULTS: The number of patients included was 53: 18 had 200 mg itraconazole daily, 17 had 400 mg itraconazole daily and 18 placebo. At days 7 and 14, significant improvement was seen in the SCORAD of the head and neck area for the groups given 400 mg itraconazole daily (P = 0.0385 and P = 0.0134), and 200 mg daily (P = 0.0104 and P = 0.0006). Patients in the placebo group improved slightly (P = 0.0785). At day 14, comparison of improvement of SCORAD of the head and neck area between all three groups showed a significant difference in favour of the 200 mg itraconazole group compared to the placebo group (P = 0.0318). The prick test was positive for Pityrosporum ovale in 37% and negative for C. albicans in all patients. CONCLUSIONS: One week of treatment with 200 or 400 mg itraconazole as a single treatment has a significant effect on the head and neck area. Compared to placebo there was a significant improvement in SCORAD of the head and neck area in favour of the 200 mg itraconazole group after 14 days. The important observation seems to be that antifungal systemic treatment has a significant SCORAD reduction of atopic dermatitis, irrespective of the presence of allergy.     

Azathioprine in severe adult atopic dermatitis: a double-blind,placebo-controlled,crossover trial

BACKGROUND: There is a limited range of treatments for severe atopic dermatitis (AD). Azathioprine has often been used but there has been no randomized controlled trial of this drug to confirm its efficacy in AD. OBJECTIVES: To establish or refute the efficacy of azathioprine in severe AD. To investigate the safety and tolerability of azathioprine in this patient population. METHODS: We performed a double-blind, randomized, placebo-controlled, crossover trial of azathioprine in adult patients with severe AD. Each treatment period was of 3 months' duration. Treatments were azathioprine 2.5 mg kg(-1) day(-1) and matched placebo. Disease activity was monitored using the SASSAD sign score. In addition, severity of pruritus, sleep disturbance and disruption of work/daytime activity were monitored using visual analogue scales. Adverse events were recorded and haematological and biochemical monitoring was performed. RESULTS: Thirty-seven subjects were enrolled, mean age 38 years (range 17-73). Sixteen were withdrawn, 12 during azathioprine treatment and four during placebo treatment. The SASSAD score fell by 26% during treatment with azathioprine vs. 3% on placebo (P < 0.01). Pruritus, sleep disturbance and disruption of work/daytime activity all improved significantly on active treatment but not on placebo. The difference in mean improvement between azathioprine and placebo was significant for disruption of work/daytime activity (P < 0.02) but not for pruritus or sleep disturbance. Gastrointestinal disturbances were reported by 14 patients during azathioprine treatment and four were withdrawn as a result of severe nausea and vomiting. Leukopenia was observed in two patients and deranged liver enzymes in eight during treatment with azathioprine. CONCLUSIONS: Azathioprine is an effective and useful drug in severe AD although it is not always well-tolerated. Monitoring of the full blood count and liver enzymes is advisable during treatment.     

Oral liarozole vs. acitretin in the treatment of ichthyosis: a phase II/III multicentre, double-blind, randomized, active-controlled study

BACKGROUND: Liarozole, a retinoic acid metabolism blocking agent, has been granted orphan drug status for congenital ichthyosis by the European Commission and the U.S. Food and Drug Administration. OBJECTIVES: The purpose of this trial was to investigate the efficacy, tolerability and safety of oral liarozole vs. acitretin in patients with ichthyosis. METHODS: In this double-blind comparative trial of liarozole vs. acitretin, 32 patients with ichthyosis were randomized to be treated with either oral liarozole 75 mg in the morning and 75 mg in the evening or with acitretin 10 mg in the morning and 25 mg in the evening for 12 weeks. Clinical efficacy, tolerability and safety were monitored. RESULTS: Between-group comparisons for efficacy and tolerability revealed no statistically significant differences except for scaling on the trunk at baseline which was significantly worse in the liarozole group (P = 0.024) and showed a more pronounced improvement in this group than in the acitretin-treated patients (P = 0.047). Based on the overall evaluation of the response to treatment at endpoint, 10 of 15 patients in the liarozole group and 13 of 16 patients in the acitretin group were considered by the investigator to be at least markedly improved. The expected retinoic acid-related adverse events were mostly mild to moderate and tended to occur less frequently in the liarozole group. No serious adverse events related to the drugs occurred. CONCLUSIONS: The present study indicates that liarozole at a daily dose of 150 mg is equally effective as a treatment for ichthyosis as acitretin but shows a trend towards a more favourable tolerability profile. The results of this trial warrant further clinical trials to confirm efficacy and safety of liarozole as an orphan drug in ichthyosis.     

How soon does cutaneous tuberculosis respond to treatment? Implications for a therapeutic test of diagnosis

BACKGROUND: It is difficult to demonstrate Mycobacterium tuberculosis in smears or biopsies and to grow it in culture in cutaneous tuberculosis because most cases are paucibacillary. A therapeutic trial of antitubercular drugs is frequently used to confirm the diagnosis in difficult cases. Information is lacking on the response to antitubercular therapy in cutaneous tuberculosis; consequently there are no clear guidelines on when to expect a response and also when to abandon a therapeutic trial. METHODS: We studied the records of 60 patients treated for cutaneous tuberculosis at our hospital to study the time course of the therapeutic response. All patients were treated with a short-course antitubercular regimen consisting of isoniazid 300 mg daily, rifampicin 450 mg daily, ethambutol 800 mg daily and pyrazinamide 1500 mg daily for 2 months followed by isoniazid and rifampicin in the same doses for 4 months. At follow-up visits, each patient was assessed by a dermatologist who recorded the presence or absence of clinical improvement in the skin lesions. RESULTS: Of the 60 patients seen, eight patients did not follow up after the initial consultation, 48 patients improved with treatment and four patients were classified as treatment failures. The timing of the first visit varied from 3 days to 15 months (median 27.5 days, mean 58.96 +/- 94.50) after initiation of treatment. Twenty-one patients were recorded to have improved within the first month of therapy. Twenty-seven patients who first reported more than 30 days after initiation of treatment were found to have improved. Four patients failed to respond during follow up ranging from 3 to 17 months. CONCLUSION: When a therapeutic trial is undertaken in cutaneous tuberculosis, 6 weeks of therapy with four drugs appears adequate to prove (or disprove) the diagnosis.     

A double-blind study of 1% metronidazole cream versus systemic oxytetracycline therapy for rosacea

In a randomized double-blind trial fifty-one patients with rosacea were treated for 2 months with either 1% metronidazole cream and placebo tablets or with 250 mg oxytetracycline tablets taken twice daily, and placebo cream (the cream base). The patients were assessed before and at the end of the trial, using the following criteria: (1) overall clinical assessment, (2) lesion counts, (3) degree of erythema, (4) independent photographic evaluation, (5) patients' opinion. An improvement was shown in 90% of the patients of both groups, and there was no significant difference between the two treatments. One per cent metronidazole cream has been shown to be significantly better than a placebo cream in the treatment of rosacea (Gamborg Nielsen, 1983a), It was therefore considered important to compare the cream with conventional therapy, and for this reason a double-blind study of 1% metronidazole cream versus a daily dose of 500 mg oxytetracycline was performed.     

Azathioprine treatment in chronic actinic dermatitis: a double-blind controlled trial with monitoring of exposure to ultraviolet radiation

Oral azathioprine was compared with placebo in a double-blind controlled trial of therapy in chronic actinic dermatitis (CAD), a rare eczematous photodermatosis. Eighteen severely affected patients were randomly allocated to azathioprine 50 mg t.d.s. or placebo over a 2-year period. Severity of itch and rash were assessed weekly by each patient on a visual analogue scale and overall clinical status monthly by a medical observer. Monitoring of patient ultraviolet radiation (UVR) exposure was undertaken throughout treatment by polysulphone film lapel-badge dosimetry. Five of 8 patients treated with azathioprine but none of 10 placebo patients achieved remission within 6 months. One patient could not tolerate treatment because of gastrointestinal effects. No haematological or hepatic abnormality was noted. The marked improvement in clinical status of actively treated patients (P less than 0.02, Fisher's exact test), led to early termination of the trial. Oral azathioprine therapy is an effective and usually well tolerated treatment in chronic actinic dermatitis.     

Doxycycline 40 mg Capsules (30 mg Immediate-Release/10 mg Delayed-Release Beads)

Anti-inflammatory dose doxycycline 40 mg capsules (30 mg immediate-release and 10 mg delayed-release beads) provide a sub-antimicrobial dose that reduces the inflammatory response in patients with rosacea without producing drug concentrations required to treat bacterial diseases. The efficacy of oral, anti-inflammatory dose doxycycline 40 mg capsules once daily in the treatment of adults with rosacea was demonstrated in two pivotal large, randomized, double-blind, placebo-controlled, multicenter trials. After 16 weeks’ therapy, anti-inflammatory dose doxycycline 40 mg was significantly more effective in improving rosacea than placebo, providing a greater reduction in the total inflammatory lesion count (primary endpoint) than placebo. Anti-inflammatory dose doxycycline 40 mg was associated with a rapid onset of action, achieving a significantly greater decrease in total inflammatory lesion count than placebo by the first follow-up visit at week 3 in both studies. Maximum anti-inflammatory efficacy appears to be achieved with doxycycline 40 mg capsules once daily, as no additional improvement in rosacea symptoms was achieved with oral doxycycline 100 mg once daily (usual antibacterial dosage) in a small, randomized, double-blind trial. Anti-inflammatory dose doxycycline 40 mg was generally well tolerated in clinical trials, with most adverse events being of mild to moderate intensity.     

Oral zinc sulphate therapy in acne vulgaris: a double-blind trial

The effect of zinc sulphate and placebo was compared in a double-blind trial in 56 patients suffering from acne vulgaris. Serum vitamin A levels were studied in all, before and at the end of therapy, 29 patients received zinc sulphate 600 mg daily and 27 patients received placebo. Patients on placebo showed no improvement. After 12 weeks of treatment with zinc sulphate, 17 patients (58%) showed significant improvement. There was a statistically significant decrease in the number of papules, infiltrates and cysts. In zinc-treated cases there was statistically significant increase in serum vitamin A levels, while no change was found in the placebo group.     

Topical clindamycin versus systemic tetracycline in the treatment of acne: Results of a multiclinic trial

In a multiclinic double-blind trial, 305 patients with moderate to severe acne vulgaris were treated with oral tetracycline hydrochloride, 250 mg (N: 103), a 1% solution of clindamycin phosphate (N: 105), or placebo (N: 97) twice daily for 8 weeks. The response to treatment was evaluated by lesion counts and overall clinical improvement at 2, 4, 6, and 8 weeks. Both topical clindamycin and oral tetracycline significantly reduced papule and pustule counts compared to placebo; they were rated significantly higher than placebo on the physician's and the patient's overall evaluation at the end of the treatment period. No serious side effects were reported with any of the study medications.     

加巴喷丁胶囊治疗疱疹后神经痛的多中心临床观察

目的 观察加巴喷丁治疗疱疹后神经痛的临床疗效和安全性.方法 多中心、随机双盲、安慰剂对照、平行设计临床试验.疱疹后神经痛患者随机分为治疗组和对照组,两组患者分别口服加巴喷丁胶囊1800 mg/d或安慰剂胶囊,总共接受6周的药物治疗.于治疗前及治疗后第1、3、6周各随访1次,进行疗效和安全性评价.以视觉模拟评分法进行疱疹后神经痛的疼痛评分作为主要观察指标,以5点严重程度评分方法进行睡眠质量评分作为次要观察指标.结果 4个中心共人选141例疱疹后神经痛患者,125例完成试验,其中试验组66例,对照组59例.与用药前相比,用药后1周、3周和6周时,两组在疼痛严重程度、睡眠质量方面均有不同程度改善;试验组在用药后1周、3周改善更为明显.用药后第1周和第3周试验组的有效率分别为29.58%和57.75%,对照组分别为13.04%和40.58%,试验组高于对照组,两组比较,差异均有统计学意义(X2CMH分别为5.94,4.12,P＜0.05).加巴喷丁有较好的耐受性,不良反应主要表现为头晕、头昏、嗜睡和转氨酶升高等.结论 加巴喷丁胶囊治疗疱疹后神经痛,能改善患者疼痛严重程度和睡眠质量,不良反应发生率低.     

Pilot study of a novel treatment for androgenetic alopecia using enriched cell culture medium: clinical trials

Androgenetic Alopecia (AA) afflicts a large part of the population and of the many treatments available today none is completely satisfactory. Testing the efficacy and safety of a novel topical treatment for AA which is based on cell culture medium supplemented with insulin, thyroxin and growth hormone (CCM). The 48 participants classified as androgenetic alopecia Type II, III or IV on the Hamilton scale, concluded a randomized, vehicle-controlled, double-blind trial of 6 months duration. Under occlusive cover the gel was self applied for at least 3 hours daily. Evaluation was based on hair counts, investigator global assessment and participants self-administered questionnaire. Cessation of hair loss was reported by most participants within 28 weeks, and further confirmed by the hair count (HC) in ~80% of participants. Moreover, as early as 4 months after the start of the treatment, a time dependent increase of up to 50% in HC was observed. The average change in HC between the two groups differed significantly (p=0.007), with values of 4.1% for control and 13.8% for CCM. Following 4 months of treatment, a time dependent increase in HC (>10%) above minimal was observed in 55% of the CCM and 25% of the control and this trend continued. At 6 months 63% of the CCM and 33% of the control group exhibited increase of HC higher than 10%. The average increase in HC in the CCM and the control groups was 17.1% and 8.9% respectively (p=0.035). Self evaluation questionnaires revealed a time dependent increase in satisfaction in the CCMusers compared to the control. While the average score at T2 was similar in CCM and control (2.7 and 2.6 respectively), the score at T6 in the CCM increased to 5.9 and decreased to -0.4 in the control (p=0.007). Global-clinical evaluation following six months treatment revealed significantly (p=0.02) more hair loss in the control group (40%) compared to the CCM (7%) treated group. CCM was found effective in treating androgenetic alopecia in men. It induced cessation of hair loss, increased rate of hair growth and appearance of new hair. No side effects were reported or observed.     

Treatment of aphthosis with thalidomide and with colchicine

Thalidomide alone (200-300 mg daily) or associated with colchicine (2-3 mg daily) was given orally to 25 patients with aphthosis: 8 patients with recurrent oral aphthae; 4 patients with recurrent mucocutaneous aphthosis, without visceral involvement, and 13 patients with Beh?et's disease (Touraine's aphthosis). A major improvement was noted in all groups, with a rapid healing of mucous lesions and a rapid reduction of pain and burning as compared to prior spontaneous regressions. No new outbreaks were noted at a dose of 50-100 mg thalidomide and 1 mg colchicine daily. Under oral administration of the drugs, thrombophlebitis was noted in 1 case (third group) only. In the other patients with Beh?et's disease, skin aphthae, ocular symptoms, arthritis, superficial nodular phlebitis quickly disappeared with treatment. The efficiency of the drugs is only temporary, since new lesions usually appeared a few weeks after the end of treatment. Due to the relatively small number of cases studied in each group, no conclusions can be drawn concerning the efficiency of thalidomide alone compared to the association of the two drugs. However, this open trial does support the usefulness of thalidomide, or thalidomide and colchicine, in recurrent mucocutaneous aphthae, aphthosis and Beh?et's disease.     

Pyridoxine in atopic dermatitis

Summary A previous study has reported benefit when pyridoxine hydrochloride was given to patients with atopic dermatitis. To investigate this in children, we performed a randomized, double-blind, parallel-group, placebo-controlled trial. Forty-eight children with moderate or severe atopic dermatitis were recruited and, of those who completed the study, 19 received pyridoxine hydrochloride 50 mg once daily for 4 weeks and 22 received placebo. Disease activity was monitored by clinical severity scores measuring the extent and degrees of erythema recorded by the investigator and symptom scores (daytime itch and nocturnal sleep disturbance) recorded by parents. There was no statistically significant difference between the two groups at the end of treatment. We have been unable to demonstrate clinical benefit from pyridoxine supplementation in children with atopic dermatitis.     

Oral R115866 in the treatment of moderate to severe plaque-type psoriasis

BACKGROUND: R115866 (Rambazole) is a new generation all-trans retinoic acid metabolism blocking agent, highly specific against the retinoic acid 4-hydroxylase. The drug alleviates hyperproliferation and normalizes differentiation of the epidermis in animal models of psoriasis. OBJECTIVE: To explore the efficacy, safety and tolerability of systemic R115866 in patients with moderate to severe plaque-type psoriasis. PATIENTS AND METHODS: In this open label, single-arm trial, patients were treated with R115866, 1 mg/day for 8 weeks, followed by a 2-week treatment-free follow-up period. Patients were monitored for efficacy and safety. RESULTS: Nineteen patients (intent-to-treat population) were treated and 14 completed the entire study. Two patients discontinued due to lack of efficacy and three due to adverse events. At the end of the treatment, 26% of the patients showed at least 50% reduction in Psoriasis Area Severity Index (PASI) compared to baseline. Further improvement was observed at the end of the 2-week follow-up period where 47% of the patients showed a 50% or greater reduction in PASI. Kinetic data showed no evidence of accumulation of either R115866 or retinoic acid in plasma. The most common adverse events were pruritus, xerosis, cheilitis and an increase in blood triglycerides. The majority of adverse events were mild to moderate. No deaths or serious adverse events were reported. CONCLUSION: Eight-week daily treatment with 1 mg R115866 resulted in a significant reduction in PASI from baseline to end of therapy. Additional improvement was seen after the 2-week follow-up period. The drug was well tolerated. R115866 merits further evaluation to optimize its clinical efficacy and safety profile in moderate to severe plaque-type psoriasis.     

Randomized, double-blind trial of 220 mg zinc sulfate twice daily in the treatment of rosacea

A 2006 article published in the International Journal of Dermatology reported that oral zinc sulfate 100 mg three times daily was associated with improvement in the severity of facial rosacea (Sharquie et al. 2006; 45: 857-861). The current study was undertaken to further assess the role of zinc in the management of rosacea. This was a randomized, double-blind trial of 220 mg of zinc sulfate twice daily for 90 days in patients with moderately severe facial rosacea at baseline. Subjects were recruited in the Upper Midwest USA between August 2006 and April 2008, and followed until July 2008. Forty-four subjects completed the trial (22 in each arm). Rosacea improved in both groups. There were no differences in magnitude of improvement based on rosacea severity scores between subjects receiving zinc sulfate and subjects receiving placebo (P=0.284). Serum zinc levels were higher in subjects receiving zinc (P<0.001). Oral zinc sulfate was not associated with greater improvement in rosacea severity compared with placebo in this study. Additional studies are needed to determine what role oral zinc may have in the management of rosacea.     

An open clinical trial of sulphamethoxypyridazine in the treatment of mucous membrane pemphigoid

Twenty-five patients with mucous membrane pemphigoid (MMP), whose oral lesions were unresponsive to topical steroid treatment, were treated with 1 g daily of sulphamethoxypyridazine (SMXP), a long-acting sulphonamide antibiotic, in an open prospective clinical trial. Lesion severity was assessed objectively in a semiquantitative fashion before treatment and after 14 weeks of treatment. The patient's subjective assessment of the associated pain or discomfort, using a visual analogue scale, was also recorded at these times. Three patients (12%) were withdrawn from the study owing to side-effects or complications, one due to an allergic reaction, the other two because of significant haemolysis. For the remainder there was a significant improvement in the mean objective clinical scores for desquamative gingivitis, other oral lesions, conjunctival inflammation, nasal, vulvovaginal and skin involvement, after 14 weeks treatment with SMXP (all P < 0.001, except skin P < 0. 01). Only conjunctival scarring showed no improvement. In addition, there was a significant improvement (P < 0.001) in the pain scores for the mouth, eyes, nose, vulvovaginal region and skin. The results indicate that with appropriate monitoring SMXP is an effective treatment for MMP and compares favourably with other systemic agents used in the management of this condition.     

Safety and efficacy of a fixed-dose cyclosporin microemulsion (100 mg) for the treatment of psoriasis

Cyclosporin is a second-line modality for the treatment of psoriasis. The long-term efficacy of cyclosporin and potential adverse side-effects, however, are a concern to patients. Therefore, a cyclosporin microemulsion (Neoral), which is steadily absorbed at an ultra-low dosage (1-2 mg/kg per day) or low dosage (2-3 mg/kg per day), is currently recommended. The dose must be calculated based on patient bodyweight and the blood concentration monitored regularly, which is time-consuming. Furthermore, the concentration is related to the safety profile, but not to efficacy. We examined whether a fixed-dose cyclosporin microemulsion (100 mg/day) is effective for treating psoriasis. Enrolled patients (n = 40) were given either 100 mg cyclosporin emulsion once daily (group A) or 50 mg twice daily (group B), regardless of patient weight and condition, before meals in a randomized controlled study. Patient bodyweight ranged 50-80 kg. We assessed the serum cyclosporin concentration 1 h after administrating the medicine (C1 score), Psoriasis Area and Severity Index (PASI) score, quality of life, and the results of regular blood examinations. The improvement rate was 69.4 ± 4.8% in group A and 73.4 ± 4.3% in group B. PASI-50 was achieved by 82% in group A and 84% in group B. At 6 weeks, the number of patients with PASI-50 was significantly higher in group A than in group B. PASI-75 and -90 were also achieved in both groups with no significant difference between groups. Administration of a fixed-dose cyclosporin microemulsion (100 mg/day) is practical for second-line psoriasis treatment.     

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.