Vehicle Gel (vehicle + gel)

Distribution by Scientific Domains

Selected Abstracts

Enamel matrix derivative and titanium implants

An experimental pilot study in the rabbit
Aim: The aim of present study was to evaluate if an enamel matrix derivative (Emdogain®) may enhance bone formation and osseointegration of titanium implants, using a well-documented rabbit model. Material and methods: Thirty-six threaded commercially pure titanium (cp.ti.) implants were inserted in six New Zealand white rabbits. One implant was placed in each femur and two in each tibia. Prior to implant insertion approximately 0.5 mL of Emdogain (EMD) (test) or the vehicle gel (PGA: propylene glycol alginate) (control) was injected into the surgically prepared implant site. The follow-up time was 6 weeks. Biomechanical evaluations by resonance frequency analysis (RFA) and removal torque measurements (RTQ) were performed. Histomorphometrical quantifications were made on ground sections by measurements of the percentage of bone-to-metal contact, bone area inside the threads as well as outside the threads (mirror image). Bone lengths along the implant surface were also measured and used for shear strength calculations. Results: The results demonstrated no beneficial effects from the EMD treatment on bone formation around titanium implants in any of the tested parameters. Significant differences were demonstrated with removal torque test and shear force calculations for the control implants. No other parameter demonstrated a statistically significant difference. Conclusion: The results of the present study may indicate that EMD does not contribute to bone formation around titanium implants. This observation may indicate that the bone formation that occurs after EMD treatment in periodontal defects is the result of functional adaptation. However, further research is required to evaluate the effect of EMD treatment on bone formation. Zusammenfassung Schmelzmatrixprotein und Titanimplantate. Eine experimentelle Pilotstudie beim Kaninchen Zielsetzung: Untersuchung im gut dokumentierten Kaninchenmodell, ob Schmelzmatrixprotein (Emdogain®) die Knochenbildung und Osseointegration von Titanimplantaten verbessert. Material und Methoden: 36 kommerziell erhältliche Schraubenimplantate aus reinem Titan (cp.ti.) wurden bei 6 weißen Neuseeländischen Kaninchen inseriert. Ein Implantat wurde in jeden Femur und 2 in jede Tibia gesetzt. Vor Implantatinsertion wurden etwa 0,5 ml Emdogain (EMD) (Test) oder das Trägergel (PGA: Propylenglykolalginat) (Kontrolle) in die chirurgisch vorbereitete Insertionsstelle gespritzt. Die Nachuntersuchungszeit betrug 6 Wochen. Die biomechanischen Untersuchungen umfassten eine Resonanzfrequenzanalyse (RFA) und die Messung des Drehmoments, das zur Entfernung der Implantate nötig war (RTQ). Folgende histomorphometrische Messungen wurden auf Schliffpräparaten durchgeführt: Messung des prozentualen Knochen-zu-Metall-Kontaktes, Knochenbereich innerhalb und außerhalb der Schraubengewinde (Spiegelbild). Die Knochenlänge entlang der Implantate wurde ausgemessen und für Scherkraftberechnungen genutzt. Ergebnisse: Es konnten für keinen der untersuchten Parameter günstige Auswirkungen der Anwendung von EMD auf die Knochenbildung um Titanimplantate beobachtet werden. Signifikante Unterschiede konnten für RTQ und Scherkraftberechnungen für die Kontrollimplantate gezeigt werden. Für keinen anderen Parameter konnten statistisch signifikante Unterschiede gefunden werden. Schlussfolgerungen: Die Ergebnisse dieser Studie zeigen, dass der Einsatz von EMD nicht zur Knochenbildung um Titanimplantate beiträgt. Diese Beobachtung kann darauf hinweisen, dass die Knochenbildung, die nach Gabe von EMD in parodontalen Defekten stattfindet, das Ergebnis funktioneller Adaptation ist. Allerdings sind weitere Untersuchungen erforderlich, um die Auswirkung von EMD auf die Knochenbildung zu verstehen. Résumé Dérivés de la matrice amellaire et implants en titane. Une étude pilote expérimentale sur le lapin. But: Le but de cette étude était d'évaluer si un dérivé de la matrice amellaire (Emdogain®) pouvait augmenter la formation osseuse et l'ostéo-intégration d'implants en titane en utilisant un modèle éprouvé de lapin. Matériel et méthodes: 36 implants en titane commercialement purs (cp.ti.) ont été vissés chez 6 lapins blancs de Nouvelle Zélande. 1 implant fut placé dans chaque fémur et 2 dans chaque tibia. Préalablement à l'insertion, environ 0.5 mL d' Emdogain (EMD) (test) ou du gel vecteur (PGA: propylene glycol alginate) (control) fut injecté dans le site implantaire préparé chirurgicalement. Le suivi était réalisé sur 6 semaines. Des évaluations biomécaniques par analyse de la fréquence de résonance (RFA) et des mesures de torque de retrait (RTQ) furent utilisées. Les quantifications histo-morphométriques furent réalisées sur des coupes en mesurant le pourcentage de contact os-métal, les surfaces osseuses à l'intérieur ainsi qu'à l'extérieur des spires (Image miroir). Les longueurs d'os le long des surfaces implantaires furent aussi mesurées et utilisées pour calculer les forces de cisaillement. Résultats: Les résultats n'ont montré aucun effet bénéfique du traitement à l'EMD sur la formation osseuse autour des implants en titane pour aucun des paramètres test. De significatives différences furent trouvées avec le test de torque et les calculs de force de cisaillement pour les implants contrôles. Aucun autre paramètre ne montrait de différences statistiquement significatives. Conclusion: Les résultats de cette étude pourrait indiquer que l'EMD ne contribue pas à la formation osseuse autour des implants en titane. Cette observation peut indiquer que la formation osseuse qui survient après traitement à l'EMD dans les lésions parodontales serait le résultat d'une adaptation fonctionnelle. Cependant, de futures recherches sont nécessaires pour évaluer l'effet du traitement à l'EMD sur la formation osseuse. [source]

PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: Results of a randomized phase IIa trial

Greg Siller
ABSTRACT Objectives:, To evaluate the safety of two applications of PEP005 (ingenol mebutate) gel in superficial basal cell carcinoma. Efficacy was a secondary end-point. Methods:, Randomized, vehicle-controlled, phase IIa study conducted at eight private dermatology clinics in Australia. A total of 60 patients with histologically confirmed superficial basal cell carcinoma (lesion size, 4,15 mm) were randomized to treatment on days 1 and 2 (Arm A) or days 1 and 8 (Arm B) and, within each arm, to ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel. The main outcome measures were the incidence and severity of adverse events and local skin responses in Arms A and B; lesion clearance at day 85 was a secondary measure. Results:, The incidence of adverse events was low. One patient treated with ingenol mebutate gel, 0.05% in Arm A experienced severe flaking/scaling/dryness extending beyond the application site. Non-severe, potentially treatment-related events included erythema extending beyond the application site, application-site pain and headache in two patients each. Six patients in Arm A had one or more severe local skin responses. Efficacy appeared to be dose-related and there was a trend towards higher clinical and histological lesion clearance rates in Arm A compared with Arm B. Histological clearance occurred in five of eight patients (63%) randomized to ingenol mebutate gel, 0.05% in Arm A. Conclusions:, Two applications of ingenol mebutate gel, 0.05%, are safe and have efficacy in patients with superficial basal cell carcinoma. [source]

PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: Results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study

Greg Siller
SUMMARY The sap of the plant Euphorbia peplus is a traditional remedy for skin conditions, including actinic keratosis. The active constituent of the sap is ingenol mebutate (ingenol-3-angelate), formerly known as PEP005. This randomized, double-blind, vehicle-controlled, phase IIa study investigated the safety (and secondarily the efficacy) of two applications of ingenol mebutate gel in 58 patients with biopsy-confirmed actinic keratosis. Five preselected lesions were treated with ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel, on days 1 and 2 (Arm A) or days 1 and 8 (Arm B). There were no significant differences in tolerability or efficacy between Arms A and B. Treatment was well tolerated. The most common local skin responses were dose-related erythema, flaking/scaling/dryness and scabbing/crusting. Efficacy was greatest with ingenol mebutate gel, 0.05%, which resulted in complete clinical clearance of 71% of treated lesions (P < 0.0001 vs vehicle gel). In addition, 67% of patients treated with ingenol mebutate gel, 0.05% had clinical clearance of at least four of five treated lesions (P = 0.0185 vs vehicle gel). Ingenol mebutate gel is being developed as a short-course topical therapy for actinic keratosis and non-melanoma skin cancer. [source]