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<p><b>Expression of surrogate markers after transdermal delivery of interferon-alpha in Transfersomes®</b> </p> <p align="left">J. Lehmann, K. Theiling, M. Klede, A. Ikoma, M. Schmelz, M. Rother, P. von Wussow</p> <p align="left">*Medizinische Biophysik, Technische Universität München<br> Ismaningerstr. 22, D-81675 München, Deutschland, EU<br> +IDEA, Innovative dermale Applikationen GmbH, Frankfurter Ring 193a,<br> D-80807 München, Deutschland, EU </p> <p align="left"><b>Int. J. Immunother.18:21-26 (2002). </b></p> <p align="left">Intravenous, intramuscular, and subcutaneous administration of IFN-alpha-2b is most commonly accompanied by side effects like fever, chills, headache, myalgia, lower back pain, nausea and vomitting. In addition, injections can cause skin necrosis. To reduce the severity of adverse effects, we investigated the feasibility of the epicutaneous route of administration for IFN-alpha-2b using Transfersome® technology, a drug delivery system consisting of ultraflexible, mixed lipid aggregates that penetrate the skin efficiently when applied nonocclusively. A subject- and observer-blinded, single dose, placebo-controlled clinical trial was performed in 11 healthy subjects to obtain data on the safety and efficacy of absorption. The amount applied on the safety test field of the inner forearm was either 6 x 10e6 IU IFN-alpha-2b in Transfersome® or placebo Transfersome® (vehicle). Dermal tolerance was analyzed by the physician's visual assessment, subject self-evaluation of itching and pain, and laser Doppler imaging for the assessment of local erythema and axon reflex erythema. To analyze transdermal transport by microdialysis, each subject additionally received 3 x 10e6 IU of IFN-alpha-2b in Transfersome® on the other forearm. Therefore, the total amount applied was either 3 or 9 x 10e6 IU IFN-alpha-2b in Transfersome® depending on the subject's dosage group. Mx protein and neopterin, two surrogate markers for IFN-alpha-2b efficacy, were determined in this study. Safety, adverse events, body temperature, and blood biochemistry/hematology were recorded. This study confirms the excellent dermal tolerance of the IFN-alpha-2b Transfersome® formulation after a single dose administration. Furthermore, the increase in surrogate markers might indicate systemic exposure of IFN-alpha-2b after transdermal delivery in Transfersome® and bioactivity of the transdermally transported IFN-alpha-2b. </p> <p><a href="index.html"><----</a> | <a href="../.././index.html" target="_top" onmouseover="putstattext('Was ist das Besondere an IDEA?'); return true;">Startseite</a> | <a href="../../about-us/index.html" target="_top" onmouseover="putstattext('Über die Geschichte, die Leute, die Zusammenarbeiten und die Zukunftspläne von IDEA.'); return true;">Über uns</a> | <a href="../../corporate_factsheet/index.html" target="_top" onmouseover="putstattext('Corporate Factsheet'); return true;">Corporate Factsheet</a> | <a href="../../science/index.html" target="_top" onmouseover="putstattext('Wissenschaftliche Kooperationen, Veröffenlichungen usw.'); return true;">Wissenschaft</a> | Publikationen | <a href="../../product_opportunities/index.html" target="_top" onmouseover="putstattext(''); return true;">Einsatzmöglichkeiten</a> | <a href="../../financial/index.html" target="_top" onmouseover="putstattext('Investoren und grundlegende finanzielle Daten.'); return true;">Finanzierung</a> | <a href="../../press_releases/index.html" target="_top" onmouseover="putstattext('Originaltexte...'); return true;">Pressemitteilungen</a> | <a href="../../latest_newsletter/index.html" target="_top" onmouseover="putstattext('IDEAS letzter ausgegebene Newsletter'); return true;">Letzter Newsletter</a> | <a href="../../press_clippings/index.html" target="_top" onmouseover="putstattext('IDEA in der Presse - die Originaltexte.'); return true;">Pressespiegel</a> | <a href="../../conferences/index.html" target="_top" onmouseover="putstattext('Bei diesen Veranstaltungen treffen sie uns, und wir können uns persönlich unterhalten...'); return true;">Konferenzen</a> | <a href="../../career/index.html" target="_top" onmouseover="putstattext('Wir suchen Talente mit Engagement und bieten im Gegenzug viel.'); return true;">Karriere</a> | <a href="../../contact/index.html" target="_top" onmouseover="putstattext('Wir freuen uns, von Ihnen zu hören!'); return true;">Kontakt</a> | <a href="../../faq/index.html" target="_top" onmouseover="putstattext('Der Unterschied zwischen Liposomen und Transversomen, Produktverträglichkeit und vieles mehr.'); return true;">Wissenschaftliche FAQ</a> | <a href="../../glossary/index.html" target="_top" onmouseover="putstattext(''); return true;">Glossar</a> | <a href="../../sitemap/index.html" target="_top" onmouseover="putstattext('Schaffen Sie sich einen Eindruck von IDEA.'); return true;">Seitenübersicht</a> | <a href="../../search/index.html" target="_top" onmouseover="putstattext('Finden Sie Dokumente in dieser Seite über Schlagwörter---'); return true;">Suchen</a> |  </p>