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Double-blind Clinical Study (double-blind + clinical_study)
Selected AbstractsAlbumin-Coated Tympanostomy Tubes: Prospective, Double-Blind Clinical Study,THE LARYNGOSCOPE, Issue 11 2004Teemu J. Kinnari MD Abstract Objectives: Coating an implant with albumin prevents adhesion of proteins, bacteria, and platelets and thus may lead to its improved and prolonged function. Previously, we have demonstrated the inhibition of binding of fibronectin, one of the most adhesive glycoproteins, on human serum albumin (HSA)-coated tympanostomy tubes and the durability of this binding inhibition in a 8-month trial. We have also demonstrated that the HSA coating inhibits the binding of Staphylococcus aureus and Pseudomonas aeruginosa to titanium plates. This prospective study evaluated the effect of albumin coating on tympanostomy tube sequelae and on the outcome of tympanostomized patients. Study Design: Double-blind, prospective, randomized clinical trial. Methods: Two otolaryngological centers in southern Finland enrolled 179 pediatric patients. Number of tube occlusions and otorrhea and tube ventilation time in the ears with HSA-coated titanium tympanostomy tubes were compared with the contralateral ear with its uncoated, otherwise identical titanium tube during a 9-month follow-up period. Results: In HSA-coated tubes, average ventilation time was slightly longer and the number of early tube occlusions significantly less (P < .05). Moreover, in patients with perioperative bleeding, the coating prolonged average ventilation time of tympanostomy tubes significantly (P < .05). Conclusions: HSA coating reduces early tube occlusions by preventing adherence of blood and secretion. [source] Double-blind clinical study reveals synergistic action between alpha-hydroxy acid and betamethasone lotions towards topical treatment of scalp psoriasisJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 1 2000K Kostarelos Abstract Objective A double-blind, single-site, split-face clinical study was organized and carried out in order to evaluate the efficacy, tolerability, and safety of a glycolic acid containing scalp lotion in conjunction with a betamethasone (as the 17-valerate) scalp application against conditions of psoriasis. Background,-hydroxy acids (AHA) have been proposed as therapeutic modalities against skin exfoliative conditions such as ichthyosis, xeroderma, and psoriasis. AHAs are hereby clinically investigated as therapeutic modalities adjuvant to corticosteroids in order to diminish systemic and topical adverse side-effects most frequently associated with use of the latter. Methods Twenty patients suffering from scalp psoriasis and other psoriatic conditions were included in a double-blind, split-face clinical study, using combinations of a 10% (w/w) glycolic acid scalp lotion, placebo lotion (excipients only), and a 0.1% (w/w) betamethasone scalp application, applied twice daily without any bandage for a period of 8 weeks. Clinical assessments were carried out by highly experienced physician evaluations based on a four-grade scale, prior to treatment and after 2, 4, 6 and 8 weeks. Results Improvement was observed in all cases included in the study following treatment with the 10% glycolic acid lotion. However, when equal parts of the 0.1% betamethasone lotion were combined, most of the treated sites were healed. Moreover, the duration of treatment required for healing was in this case reduced to approximately half of that needed when the glycolic acid or the betamethasone lotions were used separately for treatment. Conclusions The present clinical study demonstrates for the first time that the effective and well tolerated therapeutic efficacy of glycolic acid scalp lotions is enhanced when used in conjunction with a 0.1% betamethasone scalp application against scalp psoriasis. This potential offers the practising dermatologist with novel treatment modes against severe skin conditions by combining topical corticosteroid with exfoliative agent therapy. [source] 4% hydroquinone versus 4% hydroquinone, 0.05% dexamethasone and 0.05% tretinoin in the treatment of melasma: a comparative studyINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 7 2005Reyhaneh Astaneh PharmD A randomized, controlled, double-blind clinical study was conducted on 64 patients (phototypes III to V) with melasma, in order to compare 4% hydroquinone cream with a combination product, containing 4% hydroquinone, 0.05% tretinoin and 0.05% dexamethasone, that can be applied as a single cream. The aim of this study was to determine whether hydroquinone provides additional improvement when combined with tretinoin and dexamethasone. Patients were randomly divided into two groups of 32 individuals. One group received 4% hydroquinone (group A) in a cream base. The other received a cream that contains 4% hydroquinone, 0.05% tretinoin and 0.05% dexamethasone (group B). The creams were applied once daily at night and a broad spectrum sunscreen (sun protection factor 15) was used every morning. Patients were evaluated by a clinical investigator subjectively at baseline and after 4, 8 and 12 weeks of therapy. At the baseline visit, the history of melasma, such as duration of disease, patient's age, type of melasma, distribution of melasma, family history, association with pregnancy, sun exposure, genetic factors and oral contraceptive consumption, was taken. Improvement was determined subjectively compared with baseline, on a three-point scale as follows: worse, same and improved (excellent, good, moderate and slight). Descriptive statistics (the ,2 test) were used to report the characteristics of the patients in the two groups. [source] Oral cimetidine gives effective symptom relief in painful bladder disease: a prospective, randomized, double-blind placebo-controlled trialBJU INTERNATIONAL, Issue 3 2001R. Thilagarajah Objective To evaluate the efficacy of oral cimetidine as a treatment for painful bladder disease (PBD, variously described as a ,symptom complex' of suprapubic pain, frequency, dysuria and nocturia in the absence of overt urine infection) by assessing symptom relief and histological changes in the bladder wall tissue components, compared with placebo. Patients and methods The study comprised 36 patients with PBD enrolled into a double-blind clinical study with two treatment arms, i.e. oral cimetidine or placebo, for a 3-month trial. Patients were asked to complete a symptom questionnaire (maximum score 35), and underwent cystoscopy and bladder biopsy before treatment allocation. On completing treatment the patients were re-evaluated by the questionnaire and biopsy. The symptom scores and bladder mucosal histology were compared before and after treatment, and the results analysed statistically to assess the efficacy of cimetidine. Results Of the 36 patients recruited, 34 (94%) completed the study. Those receiving cimetidine had a significant improvement in symptoms, with median symptom scores decreasing from 19 to 11 (P < 0.001). Suprapubic pain and nocturia decreased markedly (P = 0.009 and 0.006, respectively). However, histologically the bladder mucosa showed no qualitative change in the glycosaminoglycan layer or basement membrane, or in muscle collagen deposition, in either group. The T cell infiltrate was marginally decreased in the cimetidine group (median 203 before and 193 after) and increased in the placebo group (median 243 and 250, P > 0.3 and > 0.2, respectively). Angiogenesis remained relatively unchanged. The incidence of mast cells and B cells was sporadic in both groups. Conclusions Oral cimetidine is very effective in relieving symptoms in patients with PBD but there is no apparent histological change in the bladder mucosa after treatment; the mechanism of symptom relief remains to be elucidated. [source] | ||||||||||