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Global Assessment Score (global + assessment_score)
Selected AbstractsIntermittent dosing of fluticasone propionate cream for reducing the risk of relapse in atopic dermatitis patientsBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2002J. Hanifin Summary Background One of the most troublesome features of atopic dermatitis (AD) is its chronic relapsing nature, and there is a lack of published evidence on the best treatment strategy for long-term management of the disease. Objectives To compare an intermittent dosing regimen of fluticasone propionate (FP) cream 0·05% (twice per week) with its vehicle base in reducing the risk of relapse when added to regular daily emollient in adult and paediatric subjects with stabilized AD. Methods Subjects (aged 3 months to 65 years) with moderate or severe AD were enrolled into an open-label Stabilization Phase of up to 4 weeks on daily emollients plus FP twice daily. Those subjects who achieved ,treatment success' (Global Assessment Score ,,2, erythema, pruritus, and papulation/induration/oedema scores ,,1) entered the double-blind Maintenance Phase. They continued with regular emollients and were randomized at a 2 : 1 ratio to either intermittent FP or vehicle, once daily 4 days per week for 4 weeks followed by once daily 2 days per week for 16 weeks. Subjects who relapsed on intermittent FP were discontinued from the study. Those who did not relapse continued for an additional 24 weeks on intermittent dosing for safety monitoring. Results A total of 372 (247 paediatric, 125 adult) subjects were enrolled into the Stabilization Phase. Of these, 348 (231 children, 117 adults) were randomized into the Maintenance Phase. Analysis of the primary efficacy parameter showed that subjects receiving intermittent FP cream (twice per week), in addition to regular daily emollients in the Maintenance Phase, were 7·7 times less likely to have an AD relapse than subjects receiving intermittent vehicle cream/emollients [Mantel,Haenszel (MH) estimate of the odds ratio, 95% confidence interval (CI) 4·6, 12·8; P < 0·001]. Paediatric subjects were 8·1 times less likely to have an AD relapse (95% CI 4·3, 15·2; P < 0·001) and adult subjects were 7·0 times less likely to have an AD relapse (95% CI 3·0, 16·7; P < 0·001). For subjects receiving intermittent FP cream/emollient, the median time to relapse could not be estimated as the majority remained controlled at 20 weeks. For those receiving intermittent vehicle/emollient, the median time to relapse was 4·7 weeks. For paediatric and adult groups, this was 5·1 and 4·1 weeks, respectively. Median exposure to FP for all subjects was 337 days. There was only one study drug-related adverse event (acne) and there were no reports of skin thinning or atrophy associated with the use of FP cream in paediatric or adult subjects. Conclusions In paediatric and adult subjects, once stabilized with regular FP treatment, the risk of relapse of AD can be significantly reduced by extended intermittent dosing with FP cream in addition to regular emollient therapy. [source] Effect of extended MMX mesalamine therapy for acute, mild-to-moderate Ulcerative ColitisINFLAMMATORY BOWEL DISEASES, Issue 1 2009Michael A. Kamm MD Abstract Background: Many patients with ulcerative colitis (UC) respond to mesalamine therapy within 8 weeks. Those not achieving remission after 8 weeks are often treated with steroids or other immunosuppressive therapies. This study aimed to determine the effect of 8 weeks' high-dose MMX mesalamine extension therapy in patients with active, mild-to-moderate UC who had previously failed to achieve complete remission in 2 phase III, double-blind, placebo-controlled studies of MMX mesalamine (SPD476-301 and -302). Methods: Patients with active, mild-to-moderate UC who did not achieve clinical and endoscopic remission after ,8 weeks' treatment with MMX mesalamine (2.4 or 4.8 g/day), ASACOL® (mesalamine) delayed-release tablets 2.4 g/day, or placebo in the phase III studies received MMX mesalamine 4.8 g/day for 8 weeks. The aim was to assess remission at week 8, defined as a total modified UC Disease Activity Index score of ,1, calculated as: scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment score and sigmoidoscopy score of ,1, no mucosal friability, and a ,1 point reduction from baseline in sigmoidoscopy score. Results: Overall, 304 patients who entered this acute extension study were evaluated; 59.5% achieved remission at week 8. Remission rates were similar irrespective of prior treatment in the initial acute phase III studies. Conclusions: Most patients with mild-to-moderate UC who fail to achieve remission with up to 8 weeks' initial mesalamine therapy can achieve clinical and endoscopic remission following a further 8 weeks' treatment with high-dose MMX mesalamine therapy, thereby avoiding step-up therapy. (Inflamm Bowel Dis 2008) [source] Improvement of Dermatochalasis and Periorbital Rhytides With a High-Energy Pulsed CO2 Laser: A Retrospective StudyDERMATOLOGIC SURGERY, Issue 4 2004Tina S. Alster MD Background. Upper eyelid dermatochalasis is typically treated with excisional blepharoplasty. The role of the CO2 laser previously had been confined to that of a vaporizing, incisional, or hemostatic tool. Over the past several years, however, ablative CO2 laser skin resurfacing has been popularized as an adjunctive treatment to blepharoplasty to minimize periorbital rhytides through its vaporizing as well as skin-tightening action. Objective. To evaluate the safety and efficacy of a high-energy pulsed CO2 laser as a stand-alone treatment for dermatochalasis and periorbital rhytides. Methods. Sixty-seven patients (skin phototypes I,IV) with mild-to-severe upper eyelid dermatochalasis and periorbital rhytides received periocular CO2 laser skin treatment. Global assessment scores of dermatochalasis and rhytides were determined by a side-by-side comparison of periocular photographs preoperatively and 1, 3, and 6 months postoperatively. In addition, caliper measurements of upper eyelids before and 1, 3, and 6 months after treatment were obtained. Results. Both dermatochalasis and periorbital rhytides were significantly improved after periocular CO2 laser skin resurfacing. Patients with more severe dermatochalasis and rhytides showed greater improvement after CO2 laser treatment than did those with mild or moderate involvement. Side effects were limited to erythema and transient hyperpigmentation. No scarring, hypopigmentation, or ectropion were observed. Conclusions. Periocular skin resurfacing with a CO2 laser can safely and effectively improve upper eyelid dermatochalasis and periorbital rhytides. [source] Pre-emptive ibuprofen arginate in third molar surgery: a double-blind randomized controlled crossover clinical trialAUSTRALIAN DENTAL JOURNAL, Issue 4 2009SL Lau Abstract Background:, This study evaluated the effectiveness of 400 mg ibuprofen arginate either as a pre-emptive (PRE group) or postoperative (POST group) analgesic using a common dental pain model. Methods:, A randomized double-blind crossover clinical trial involving a series of consecutive patients admitted for bilateral third molar surgery. Results were analysed according to the self-reported pain score and the pattern of rescue medication taken. Results:, The mean pain score ranged from 0.73 to 1.60 for the PRE group and 0.47 to 1.41 for the POST group among 30 included subjects. The mean time point when first rescue medication taken was 7.3 hours and 8.3 hours postoperative, respectively. Nine patients (30 per cent) in the PRE group and 12 patients (40 per cent) in the POST group took no rescue medication. There was no statistically significant difference for all parameters between groups, while a majority (53 per cent) found the drug "good" to "excellent" in both groups. Conclusions:, Ibuprofen arginate may be considered effective in reducing surgically induced moderate to severe pain when administered either pre-operatively or postoperatively due to the reported relatively low pain score, less consumption of rescue medication, delayed onset of pain, good number of pain-free patients and a high rating in the global assessment score. [source] Yellow Nail Syndrome in Three Siblings: A Randomized Double-Blind Trial of Topical Vitamin EPEDIATRIC DERMATOLOGY, Issue 4 2006Emily M. Lambert M.D. It has rarely been reported in children and this is the first report of congenital yellow nails in siblings. The purpose of this study was to determine whether topical vitamin E applied to the nail plates and periungual skin would affect the growth rate or appearance of the fingernails in patients with congenital yellow nail syndrome. This study was the first trial of a treatment for this entity in children and the largest randomized double blind trial to date. We found that vitamin E solution had no significant effect (p = 0.84) on fingernail growth or the global appearance score (p = 1.0) when compared with placebo. The average growth rates and global assessment scores improved and onycholysis and onychomadesis decreased from baseline with both vitamin E and placebo treatment, although these were not primary end points of the study. Topical vitamin E did not result in a statistically significant improvement when compared with oil alone for the treatment of the nails in our three patients with yellow nail syndrome. However, it is interesting and perhaps clinically useful that both vitamin E and placebo oil improved the condition of the nails. [source] | ||||||||||