The safety and efficacy of ciclopirox olamine for the treatment of seborrheic dermatitis

Ciclopirox olamine is a synthetic hydroxypiridone derived, broad spectrum, antifungal agent which has been used effectively to treat seborrheic dermatitis. Seborrheic dermatitis is a chronic dermatosis, more common in men than women, which usually occurs in sites dense with sebaceous glands in the form of mild inflammatory desquamate erythema. Treatment modalities for seborrheic dermatitis include keratolytic agents, corticosteroids and antifungal agents. Due to its antimycotic and anti-inflammatory activities, ciclopirox olamine is established as an effective treatment for this condition.     

Absorption and efficacy of miconazole nitrate 0.25% ointment in infants with diaper dermatitis

BACKGROUND: The potential for toxicity from systemic absorption of topical miconazole in infants is a concern. OBJECTIVE: To assess the relative safety of 0.25% miconazole based on the amount absorbed through the skin of infants with diaper dermatitis after multiple applications. METHODS: Of 24 infants with moderate to severe diaper dermatitis, 19 received 0.25% miconazole nitrate ointment and 5 received 2% miconazole nitrate cream for 7 days at each diaper change and after bathing. Blood samples were collected prior to treatment and after 7 days. RESULTS: In the 0.25% treatment group, blood concentrations of miconazole were nondetectable (< 1 ng/mL) in 83% (15/18) and minimal (3.0 to 3.8 ng/mL) in 17% (3/18). Samples were missing for one patient. For the 5 infants in the 2% treatment group, miconazole concentration was nondetectable in 20% (1/5) and less than 7.4 ng/mL in 4 infants. No adverse events were noted. CONCLUSIONS: Systemic absorption of 0.25% miconazole nitrate ointment was minimal, demonstrating its safety in the treatment of moderate to severe diaper dermatitis.     

Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis

ABSTRACT

Objective: To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle in the treatment of bacterial conjunctivitis.

Research design and methods: This was a randomized, multicenter, double-masked, vehicle-controlled study. A total of 957 patients aged 1 year and older with bacterial conjunctivitis were randomized to treatment with besifloxacin ophthalmic suspension 0.6% or vehicle applied topically three times daily for 5 days.

Main outcome measures: Primary endpoints were clinical resolution and microbial eradication of baseline bacterial infection at Visit 2 (Day 5?±?1). Secondary endpoints included clinical resolution and microbial eradication at Visit 3 (Day 8 or 9), individual clinical outcomes at follow-up visits, and safety.

Clinical trial registration: NCT number, NCT00347932.

Results: Three hundred and ninety patients had culture-confirmed bacterial conjunctivitis. Clinical resolution and microbial eradication were significantly greater with besifloxacin ophthalmic suspension than with vehicle at Visit 2 (45.2% vs. 33.0%, p?=?0.0084; and 91.5% vs. 59.7%, p?<?0.0001, respectively) and Visit 3 (84.4% vs. 69.1%, p?=?0.0011; and 88.4% vs. 71.7%, p?<?0.0001, respectively). Results for secondary endpoints of individual clinical outcomes were consistent with primary endpoints. Fewer eyes receiving besifloxacin ophthalmic suspension experienced adverse events than those receiving vehicle (9.2% vs. 13.9%; p?=?0.0047).

Conclusions: Besifloxacin ophthalmic suspension produces clinical resolution and microbial eradication rates significantly better than vehicle and is safe for the treatment of bacterial conjunctivitis.

Limitations: A limitation of this study is the lack of a non-treatment control group.     

A review of the pathophysiology,prevention and treatment of irritant diaper dermatitis

SUMMARY

Irritant diaper dermatitis (IDD) is a form of contact dermatitis occurring in the diaper area as a consequence of disruption of the barrier function of the skin through prolonged contact with faeces and urine. Despite advances in diaper technology, it is a condition that still occurs regularly in young children. To combat this, barrier preparations can be used to protect the skin by coating the surface of the skin and/or by supplying lipids that can penetrate the intercellular spaces of the stratum corneum. In this review, the pathophysiology of IDD is outlined and its prevention and treatment are discussed, with particular reference to the role of emollients.     

A review of the pathophysiology, prevention and treatment of irritant diaper dermatitis

Irritant diaper dermatitis (IDD) is a form of contact dermatitis occurring in the diaper area as a consequence of disruption of the barrier function of the skin through prolonged contact with faeces and urine. Despite advances in diaper technology, it is a condition that still occurs regularly in young children. To combat this, barrier preparations can be used to protect the skin by coating the surface of the skin and/or by supplying lipids that can penetrate the intercellular spaces of the stratum corneum. In this review, the pathophysiology of IDD is outlined and its prevention and treatment are discussed, with particular reference to the role of emollients.     

地屈孕酮治疗痛经有效性及安全性的前瞻性、随机对照、开放标签、多中心临床研究

目的 评估地屈孕酮治疗痛经的有效性及安全性.方法 采用前瞻性、随机对照、开放标签、多中心临床研究.108例痛经患者按1:1比例随机分配到地屈孕酮组和对照组,每组54例.地屈孕酮组于月经周期第5～25天,口服地屈孕酮10 mg,每天2次,治疗3个月经周期.对照组于月经干净开始持续至下次月经第3天,口服桂枝茯苓胶囊0.93...     

Efficacy,tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter,open-label observational study*

ABSTRACT

Objective: To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% (Ganfort^?) among German patients.

Methods: Multicenter, observational, open-label study of patients with primary open angle glaucoma or ocular hypertension (n?=?606). As determined by participating physicians, patients had insufficient IOP control and required a medication change. They were switched to once-daily fixed-combination bimatoprost/timolol with no wash-out period. IOP was recorded at treated baseline, 4–6 weeks and 12 weeks after switching. Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded.

Results: A total of 405 patients switched from monotherapy, 97 switched from other fixed combinations, and 104 switched from non-fixed combinations. Among all patients, 32.5% had used prostaglandin analog (PGA) monotherapy, 8.7% had been using a fixed combination that included a PGA, and 6.9% had been using an adjunctive combination of a PGA and a β-blocker. Mean treated baseline IOP (±SD) for all patients was 20.7?±?3.5?mmHg. Overall, changing medication to fixed-combination bimatoprost/timolol lowered IOP to 16.6?±?2.7?mmHg (p?<?0.001 vs. baseline) after 4–6 weeks and to 16.1?±?2.6?mmHg (p?<?0.001) after 12 weeks; reductions of 19.8% and 22.2%, respectively. Combined bimatoprost/timolol provided an additional IOP reduction versus baseline in most subgroups based on prior treatment. At week 12, patients who had previously used a β-blocker achieved an additional 25.8% decrease from baseline and IOP was reduced by 22.6% in former PGA monotherapy patients. At week 12, 84.6% of all eyes reached a target pressure less than or equal to 18?mmHg. Tolerability of bimatoprost/timolol was rated excellent or good by the physicians for 98.7% of patients and by 96.7% of the patients themselves. Few adverse events occurred during the treatment period.

Conclusions: Although this study was limited by its observational design, our results show that the fixed combination of bimatoprost 0.03%/timolol 0.5% was effective, well tolerated, and safe in a broad patient population.     

克霉唑霜、鱼肝油软膏联合治疗尿布皮炎临床观察

目的：观察克霉唑霜与鱼肝油软膏联合治疗尿布炎的疗效，并与皮炎平霜相比较。方法：采用随机、开放性对照研究，观察组120例给予克霉唑霜与鱼肝油软膏的混合外用，对照组100例外用皮炎平霜，观察皮损消失时间。结果：两组病例的总有效率24h为89％，47％；48h为96％、74％；72h为98％，78％，两组比较有极显著差异（P＜0．01），结论：克霉唑霜与鱼肝油软膏联合治疗尿布皮炎具有见效快、疗效高等特点，值得临床推广。     

A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence

The purpose of this study was to compare the efficacy and safety of aripiprazole with placebo in the treatment of alcoholics. In this 12-week multicenter, double-blind study, 295 patients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition alcohol dependence were randomized to treatment with aripiprazole (initiated at 2 mg/d, titrated to a maximum dose of 30 mg/d at day 28) or placebo after screening, wherein patients maintained alcohol abstinence for 3 days or more. The primary efficacy measure was the percentage of days abstinent over 12 weeks. Discontinuations (40.3% vs 26.7%) and treatment-related adverse events (82.8% vs 63.6%) were higher with aripiprazole than with placebo. Mean percentage of days abstinent was similar between aripiprazole and placebo (58.7% vs 63.3%; P = 0.227). Percentage of subjects without a heavy drinking day and the time to first drinking day were also comparable between groups, although the aripiprazole group had fewer drinks per drinking day (4.4 vs 5.5 drinks; P < 0.001). The aripiprazole group showed a larger decrease in percent carbohydrate-deficient transferrin, a biomarker of heavy alcohol consumption at weeks 4 (-14.91% vs -2.23%; P = 0.020) and 8 (-16.92% vs -5.33%; P = 0.021), although not at week 12 (-9.06% vs -4.12%; P = 0.298). At study end point, aripiprazole-treated subjects reported more positive subjective treatment effects and less overall severity of alcohol dependence than placebo-treated subjects. Although there was no difference between aripiprazole and placebo on the primary end point, possibly because of dose-related attrition, effects on the secondary outcomes suggest that further study of aripiprazole for treatment of alcohol dependence may be warranted at lower doses.     

Oral doxycycline with topical tacrolimus for treatment of stasis dermatitis due to chronic venous insufficiency: A pilot study

Objectives:

Chronic venous insufficiency (CVI) in lower limbs manifest as stasis dermatitis. The anti-collagenase, anti-inflammatory and immunomodulatory effects of doxycycline and the T-cell inhibitory effects of tacrolimus could theoretically modify the disease pathophysiology. This study was undertaken to evaluate the efficacy and safety of four weeks combination therapy of oral doxycycline 100 mg with topical tacrolimus 0.1% for stasis dermatitis associated with CVI.

Materials and Methods:

A single-arm, interventional pilot study was conducted on subjects with CVI of C4 to C6 category (CEAP classification: clinical, etiology, anatomical, pathophysiology). Treatment duration was four weeks with fortnightly follow-ups. Primary efficacy was assessed as changes from baseline of pigmentation, erythema, edema, itching and hair loss of the affected area evaluated on Likert scale scores. Secondary efficacy parameters were percentage improvement of the dermatitis area and changes in ulcer dimensions (maximum length and breadth), if present. Safety evaluation included all treatment emergent clinical signs and symptoms reported by the patients and/or observed by the physician.

Results:

Out of 19 recruited subjects, 15 completed the study for analysis. Significant (P<0.01) improvement in pain, edema, pigmentation, erythema and exudation were observed. Reduction of ulcer dimensions was also statistically significant (P<0.01). 86.6% showed improvement of the dermatitis area, 6.7% patients failed to show any improvement and 6.7% showed worsening. Adverse effects were observed in only two subjects.

Conclusion:

This pilot study suggests efficacy of this combination therapy in controlling features of stasis dermatitis but further studies are needed for validation.KEY WORDS: Chronic venous insufficiency, doxycycline, MMP inhibitors, tacrolimus, varicose ulcer     

A multicenter, randomized, vehicle-controlled clinical study to examine the efficacy and safety of MAS063DP (Atopiclair) in the management of mild to moderate atopic dermatitis in adults

BACKGROUND: MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis. DESIGN: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US. METHODS: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication. RESULTS: MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event. CONCLUSION: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.     

A comparative study to evaluate efficacy,safety and cost-effectiveness between Whitfield's ointment + oral fluconazole versus topical 1% butenafine in tinea infections of skin

Aims and Objectives:

The aim of this study is to compare the efficacy, safety and cost-effectiveness of topical Whitfield''s ointment plus oral fluconazole with topical 1% butenafine in tinea infections of the skin.

Materials and Methods:

Patients were randomly allocated to the two treatment groups and advised to apply either agent topically twice-a-day for 4 weeks on the lesions and fluconazole (150 mg) was administered once a week for 4 weeks in the study group applying Whitfield''s ointment. Patients were followed-up at an interval of 10 days for clinical score and global evaluation response was assessed at baseline and during each follow-up.

Results:

Out of 120 patients enrolled in the study 103 completed the study. Patients treated with Whitfield''s ointment and oral fluconazole reduced mean sign and symptom score from 8.81 ± 0.82 to 0.18 ± 0.59 while butenafine treated patients reduced it from 8.88 ± 0.53 to 0.31 ± 0.67 at the end of the treatment. Nearly, 98% patients were completely cleared of the lesion on the 3^rd follow-up with both treatments.

Conclusion:

Whitfield''s ointment with oral fluconazole is as efficacious, safe and cost-effective as compared with 1% butenafine in tinea infections of the skin.KEY WORDS: Butenafine, fluconazole, tinea infections, Whitfield''s ointment     

A multicenter,randomized, parallel-group,clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis

Abstract

Objective:

To compare the efficacy and safety of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in a Chinese population with ocular inflammation associated with blepharokeratoconjunctivitis (BKC).     

The safety and efficacy of clindamycin phosphate foam 1% versus clindamycin phosphate topical gel 1% for the treatment of acne vulgaris

Clindamycin phosphate is the most widely used topical antibacterial agent for acne treatment. Treatment of patients with mild to moderate acne vulgaris with a new foam formulation (clindamycin foam, CF) for 12 weeks was at least as effective as clindamycin gel (CG) based on the Investigator's Static Global Assessment (ISGA) score. CF was superior to CG based on the reduction from baseline in total (P = .0014), inflammatory (P = .0478), and noninflammatory (P = .0037) acne lesion counts. Additionally, CF achieved efficacy that was superior to that of vehicle foam based on ISGA score (P = .0025) and all 3 lesion counts (all P < .05). Adverse experiences in the active treatment groups were mild or moderate and transient in nature. Thus the foam formulation of clindamycin is a safe and effective acne treatment; the unique foam delivery vehicle may offer cosmetic benefits to the patient and thus increase compliance.