Placebo Gel (placebo + gel)

Distribution by Scientific Domains

Selected Abstracts

The efficacy of nicotinamide gel 4% as an adjuvant therapy in the treatment of cutaneous erosions of pemphigus vulgaris

Fariba Iraji
ABSTRACT The high rate of morbidity and mortality resulting from long-term use of corticosteroids in pemphigus vulgaris (PV) warrants discovery of a new treatment strategy. Based on the pathophysiology of PV, nicotinamide can block the process of blister formation through its anti-inflammatory properties. This study was conducted to evaluate the clinical effectiveness of nicotinamide gel in the treatment of skin lesions of PV. In a double-blind, placebo-controlled study, eight PV patients with a total of 60 skin lesions were treated by either nicotinamide or placebo gel. After 30 days of treatment, epithelialization index of the two groups was compared. The mean of the epithelialization index in skin lesions that received nicotinamide was significantly higher than that of the placebo group (26 vs. ,5.8, p < 0.001). Our results were suggestive that nicotinamide gel can effectively be used as an adjunctive treatment for PV lesions. [source]

Intratumoral cisplatin/epinephrine gel in advanced head and neck cancer: A multicenter, randomized, double-blind, phase III study in North America,

Dan J. Castro MD
Abstract Background. The objective was to evaluate the efficacy and safety of a novel intratumoral cisplatin/epinephrine injectable gel (CDDP/epi gel) for local control and palliation of tumor-related symptoms in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients and Methods. Eighty-seven patients were randomly assigned to either CDDP/epi or placebo gel in this phase III, double-blind study. Tumors were ,20 cm3; most recurrences (88%) were in a previously irradiated field. The most symptomatic or threatening tumor was designated as the target tumor. Dose: 0.25 mL CDDP/epi gel/cm3 tumor volume. Treatments: ,6 weekly intratumoral injections in an 8-week period. Primary outcomes: target tumor response and symptom relief. Results. During the blinded phase, 34% (21 of 62) of patients achieved an objective response (CR or PR) in the target tumor treated with CDDP/epi gel vs 0% (0 of 24) treated with placebo gel (p < .001). Responses occurred within a median of four treatments (range, 2,6) and were durable (median, 95 days; range, 34,168+ days). More patients treated with CDDP/epi gel achieved palliative benefit than did those treated with placebo gel (37% vs 12%, p = .036). Most frequent side effects were local pain and local cutaneous reactions, which resolved over 3,12 weeks. Renal and hematologic toxicities were rare. Conclusions. This phase III trial showed that CDDP/epi gel significantly reduces tumor burden, palliates tumor-related symptoms, and is an effective local treatment for recurrent tumors. © 2003 Wiley Periodicals, Inc. Head Neck 25: 717,731, 2003 [source]

Octenidine in root canal and dentine disinfection ex vivo

L. Tandjung
Abstract Aim, The aim of the present study was to investigate the antimicrobial activity of octenidine on Enterococcus faecalis ATCC 29212 in a dentine block model. Methodology, Fifty-six root segments of extracted human teeth were infected with E. faecalis for 4 weeks. Octenidine-phenoxyethanol gel (1 : 1) was applied for different timing: 1 min, 10 min, 7 days and in a different formula (1 : 3) for 10 min. Three samples were chosen for the group with placebo gel and for the group without infection (negative control). Dentine samples were collected, and the total count of bacteria and colony-forming units were determined. In addition, for controls and the 10 min group with 1 : 1 gel, the proportion of viable bacteria (PVB) was assessed. Results, Octenidine was particularly effective after incubation periods of 10 min and 7 days. The mean PVB decreased significantly from 57.2% to 5.7% after 10 min application. After 7 days, only one of 10 samples showed positive culture. Conclusion, The present study showed the effectiveness of octenidine against E. faecalis in dentine disinfection. Further laboratory and clinical studies are required. [source]

Efficacy of a 0.5% chlorhexidine gel on the control of gingivitis in Brazilian mentally handicapped patients

C. M. Pannuti
Abstract Objective: To evaluate the effectiveness of a 0.5% chlorhexidine gel on the reduction of interdental gingival bleeding. Material and Methods: Forty-three mentally handicapped subjects, living in an institution (Casas André Luiz, Brazil), were enrolled in a double-blind randomised clinical trial. The subjects were randomly divided into two groups: test (chlorhexidine gel) and control (placebo gel). The gel was applied with trays, twice a day, over a period of 8 weeks. The interdental bleeding index (IBI) was recorded before and after the period in which the gel was used. Results: Statistical analysis showed that baseline IBI scores were similar (p=0.82) for test and control groups (55.6% and 54.5%, respectively). After 8 weeks, a statistically significant (p<0.001) decrease in IBI means took place in the test group (33.2%). The control group presented a small increase (60.6%) in IBI scores. The difference between groups was significant at the end of the study (p<0.001). Conclusion: The results indicated that the use of a 0.5% chlorhexidine gel was effective in reducing interdental gingival bleeding in special patients. Zusammenfassung Die Effizienz von 0,5% Chlorhexidin-Gel bei der Gingivitisprophylaxe von geistig behinderten Kindern in Brasilien Ziel: Die Evaluation der Effektivität von 0,5% Chlorhexidin-Gel bei der Reduktion der approximalen Gingivablutung Material und Methoden: Dreiundvierzig behinderte Kinder einer Institution (Casas André Luiz, Brasilien), wurden in eine randomisierte klinische Doppel-Blind-Studie aufgenommen. Die Teilnehmer wurden randomisiert in zwei Gruppen aufgeteilt: Test (Chlorhexidin-Gel) und Kontrolle (Plazebo-Gel). Während einer Periode von 8 Wochen wurde das Gel zweimal täglich mit Tiefziehschienen appliziert. Der Approximalraum-Blutungs-Index (IBI) wurde vor und nach der Periode, in der das Gel verwendet wurde, erhoben. Ergebnisse: Die statistische Analyse zeigte, dass die Ausgangswerte für den IBI für die Test- und die Kontrollgruppe ähnlich (p=0.82) waren (55,6% bzw. 54,5%). Nach 8 Wochen ergab sich in der Testgruppe ein statistisch signifikanter (p<0,001) Abfall der IBI Mittelwerte (33,2%). Die Kontrollgruppe präsentierte sich mit einer geringen Erhöhung (60,6%) der IBI-Werte. Bei Beendigung der Studie waren die Unterschiede zwischen den Gruppen signifikant (p<0,001). Schlussfolgerung: Die Ergebnisse zeigten, dass bei speziellen Patienten die Verwendung von 0,5% Chlorhexidin-Gel in der Reduktion der approximalen Gingivablutung effektiv war. Résumé Efficacité d'un gel de chlorhexidine à 0.5% sur le contrôle de la gingivite chez des patients brésilien handicapés mentaux. Objectif: Evaluer l'efficacité d'un gel de chlorhexidine à 0.5% sur la réduction du saignement gingival interdentaire. Matériel et Méthodes: 43 sujets handicapés mentaux vivant dans une institution (Casas André Luiz, Brésil), furent enrôlés dans une étude randomisée en double aveugle. Les sujets furent aléatoirement divisés en deux groupes: test (gel de chlorhexidine) et contrôle (gel placebo). Le gel fut appliqué avec des plaques 2 fois par jour pendant 8 semaines. L'indice de saignement interdentaire (IBI) fut enregistré avant et après la période d'utilisation du gel. Résultats: L'analyse statistique a montré que les notes d'IBI initiales étaient similaires (p=0.82) pour les groupes test et contrôle (55.6% et 54.5%, respectivement). Après 8 semaines, une diminution statistiquement significative (p<0.001) de l'IBI moyen apparut dans le groupe test (33.2%). Le groupe contrôle présentait une petite augmentation (60.6%) des notes d' IBI. La différence entre les groupes était significative à la fin de l'étude (p<0.001). Conclusion: Ces résultats indiquent que l'utilisation d'un gel de chlorhexidine à 0.5%était efficace pour réduire le saignement gingival interdentaire chez des patients spéciaux. [source]

Efficacy of topical griseofulvin in treatment of tinea corporis

MYCOSES, Issue 3 2006
Mohamed A. A. Kassem
Summary Tinea infections are among the most common dermatological conditions throughout the world. Griseofulvin is a classical oral fungistatic antibiotic, active against Epidermophyton floccosum, Trichophyton and Microsporum species, the causative fungi of tinea corporis. To evaluate the efficacy of topical griseofulvin in the treatment of tinea circinata using three different vehicles for drug delivery. Sixteen patients with tinea circinata were instructed to apply either griseofulvin gel form in group A or a similar placebo gel for control group; a niosomal gel formulation of griseofulvin for group B or; a liposomal gel formulation of griseofulvin for group C. Patients were evaluated both clinically and mycologically after 3 weeks. Marked improvement was seen for groups A, B and C both clinically and mycologically while no improvement was observed in the placebo group. Mild and transient irritation was reported in four patients. Our results show that topical griseofulvin preparations may be effective and safe in treating tinea circinata and that further large-scale studies may establish the high efficacy of the niosomal gel formulation. [source]

ORIGINAL ARTICLE: Safety Analysis of the Diaphragm in Combination with Lubricant or Acidifying Microbicide Gels: Effects on Markers of Inflammation and Innate Immunity in Cervicovaginal Fluid

Deborah J. Anderson
Objective, Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. Method of study, Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex® (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORMÔ (Instead Inc., La Jolla, CA, USA) or BufferGelÔ (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly®; Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. Results, Use of diaphragms with placebo or microbicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. Conclusion, Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations. [source]

Preventive effect of iron gel with or without fluoride on bovine enamel erosion in vitro

MG Bueno
Abstract Background:, The aim of this study was to evaluate the preventive effect in vitro of experimental gel containing iron and/or fluoride on the erosion of bovine enamel. Methods:, To standardize the blocks (n = 80), specimens (4 × 4 mm) were previously selected to measure the initial microhardness. The blocks were randomly allocated into four groups of 20 samples each: C (control, placebo gel); F (fluoride gel, 1.23% NaF); Fe (iron gel, 10 mmol/L FeSO4) and F + Fe (fluoride + iron gel). The gels were applied and removed after 1 minute. The blocks were then submitted to six alternating remineralization and demineralization cycles. The beverage Coca-Cola® (10 minutes, 30 mL) was used for demineralization, and artificial saliva (1 hour) for remineralization. The effect of erosion was measured by wear analysis (profilometry). Data were analysed by ANOVA and the Tukey test for individual comparisons (p <0.05). Results:, The mean wear (± SD, ,m) was C: 0.94 ± 0.22; F: 0.55 ± 0.12; Fe: 0.49 ± 0.11 and F + Fe: 0.55 ± 0.13. When the experimental gels were used, there was statistically significant reduction in enamel wear in comparison with the control (p <0.001). However, the experimental gels did not differ significantly among them. Conclusions:, The gels containing iron with or without fluoride are capable of interfering with the dissolution dental enamel in the presence of erosive challenge. [source]

Short-term clinical effects of commercially available gel containing Acacia arabica: a randomized controlled clinical trial

AR Pradeep
Abstract Background:, Certain plants used in folk medicine serve as a source of therapeutic agent by having antimicrobial and other multi-potential effects. This prospective, randomized, placebo and positively controlled clinical trial was designed to evaluate the short-term clinical effects of a commercially available gel containing Acacia arabica in the reduction of plaque and gingival inflammation in subjects with gingivitis. Methods:, Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: Group I , placebo gel, Group II , gumtone gel and Group III , 1% chlorhexidine gel. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index at baseline, 2 weeks, 4 weeks and 6 weeks. A subjective evaluation was undertaken by questionnaire. Results:, Gumtone gel showed significant clinical improvement in gingival and plaque index scores as compared to a placebo gel. This improvement was comparable to 1% chlorhexidine gel. Unlike chlorhexidine gel, gumtone gel was not associated with any discolouration of teeth or unpleasant taste. Conclusions:, Gumtone gel may be a useful herbal formulation for chemical plaque control agent and improvement in plaque and gingival status. [source]