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Sponsored by: |
MEDA Pharma GmbH & Co. KG |
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Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00777127 |
This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.
Condition | Intervention | Phase |
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Actinic Keratosis |
Drug: Imiquimod Drug: Diclofenac |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp (LEIDA) |
Estimated Enrollment: | 240 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Aldara 5% Cream
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Drug: Imiquimod
One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.
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2: Active Comparator
Solaraze 3% Gel
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Drug: Diclofenac
Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Safety concerns:
Lack of suitability for the study:
Administrative reasons:
Contact: Jenny Cadée, PhD | +31 30 258 ext 46 21 | cadee.jenny@kendle.com |
Contact: Silke Kern | +49 6172-888 ext 2300 | silke.kern@medapharma.de |
Austria | |
Medical University Vienna, Department for General Dermatology | Recruiting |
Vienna, Austria, A-1090 | |
Contact: Rainer Kunstfeld, MD, Prof. +43 1 40400 ext 6262 rainer.kunstfeld@meduniwien.ac.at | |
Medical University Innsbruck, University Clinic for Dermatology and Venereology | Not yet recruiting |
Innsbruck, Austria, A-6020 | |
Contact: Peter Fritsch, MD, Prof. +43 512 504 ext 22990 peter.fritsch@i-med.ac.at | |
Hospital Feldkirch, Department for Dermatology and Venereology | Recruiting |
Feldkirch, Austria, A-6807 | |
Contact: Robert Strohal, MD +43 5522 303 ext 7526 robert.strohal@lkhf.at | |
Medical University Graz, University Clinic for Dermatology and Venereology | Recruiting |
Graz, Austria, A-8036 | |
Contact: Peter Wolf, MD, Prof. +43 316 385 ext 7092 peter.wolf@meduni-graz.at | |
France | |
CHU Nice - Hospital Archet 2, Department for Dermatology | Recruiting |
Nice, France, F-06202 | |
Contact: Jean-Paul Ortonne, Prof. +33 4 92 03 64 ext 88 jean-paul.ortonne@unice.fr | |
Hospital Saint-Louis, Derpartment for Dermatology | Recruiting |
Paris, France, F-75010 | |
Contact: Nicole Basset-Seguin, Prof. +33 1 53 72 20 ext 66 nicole.basset-seguin@sls.aphp.fr | |
CHU St Jacques, Department for Dermatology | Recruiting |
Besancon Cedex, France, F-25030 | |
Contact: Philippe Humbert, Prof. +33 3 81 21 83 ext 01 philippe.humbert@univ-fcomte.fr | |
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology | Recruiting |
Pierre Benite, France, F-69495 | |
Contact: Catherine Goujon, MD +33 4 78 86 41 ext 25 catherine.goujon@chu-lyon.fr | |
Hospital Tenon, Department for Dermatology | Not yet recruiting |
Paris, France, F-75020 | |
Contact: Olivier Chosidow, Prof. +33 1 56 01 76 ext 70 olivier.chosidow@tnn.aphp.fr | |
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor | Recruiting |
Marseille, France, F-13009 | |
Contact: Jean-Jacques Grob, Prof. +33 4 91 74 47 ext 08 jean-jacques.grob@mail.ap-hm.fr | |
Germany | |
University Clinic Düsseldorf, Clinic for Dermatology | Recruiting |
Düsseldorf, Germany, D-40255 | |
Contact: Karl-Werner Schulte, MD, Prof. +49 211811 ext 8066 | |
Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology | Recruiting |
Berlin, Germany, D-10117 | |
Contact: Eggert Stockfleth, MD, Prof. +49 30 450 518 ext 266 eggert.stockfleth@charite.de | |
SCiderm GmbH | Recruiting |
Hamburg, Germany, D-20354 | |
Contact: Volker Steinkraus, MD, Prof. +49 40 554401 ext 0 info@dermatologikum.de | |
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology | Not yet recruiting |
Kiel, Germany, D-24105 | |
Contact: Axel Hauschild, MD, Prof. +49 431 597 ext 1853 ahauschild@dermatology.uni-kiel.de | |
Medical practice | Not yet recruiting |
Düsseldorf, Germany, D-40210 | |
Contact: Ullrich Hengge, MD, Prof. +49 211 811 ext 8066 ullrich.hengge@uni-duesseldorf.de | |
Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics | Recruiting |
Mönchengladbach, Germany, D-41061 | |
Contact: Rolf Ostendorf, MD +49 2161 ext 182475 ostendorf-rolf@t-online.de | |
University Clinic Münster, Clinic and Polyclinic for Skin Diseases | Recruiting |
Münster, Germany, D-48149 | |
Contact: Thomas Luger, MD, Prof. N.N. derma@uni-muenster.de | |
Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center | Recruiting |
Mainz, Germany, D-55131 | |
Contact: Petra Staubach, MD +49 6131 17 ext 5244 stephan.grabbe@ukmainz.de | |
Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology | Recruiting |
Frankfurt am Main, Germany, D-60590 | |
Contact: Diamant Thaci, MD +49 69 6301 ext 6556 Thaci@em.uni-frankfurt.de | |
Clinic University Regensburg, Clinic and Polyclinic for Dermatology | Recruiting |
Regensburg, Germany, D-93053 | |
Contact: Rolf Szeimies, MD, Prof. +49 941 944 ext 9614 rolf-markus.szeimies@klinik.uni-regensburg.de | |
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology | Recruiting |
Magdeburg, Germany, D-39120 | |
Contact: Harald Gollnick, MD, Prof. +49-391-671 ext 5249 harald.gollnick@medizin.uni-magdeburg.de |
Principal Investigator: | Harald Gollnick, MD, Prof. | Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology |
Study Director: | Ursula Petzold, PhD | MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany |
Responsible Party: | n.a. ( Dr. Joachim Maus / Director, Clinical Development ) |
Study ID Numbers: | X-03016-3271, EudraCT:2007-004884-24 |
Study First Received: | October 21, 2008 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00777127 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices |
actinic keratosis invasive SCC in situ SCC histological classification |
histological progression clinical clearance cryotherapy |
Anti-Inflammatory Agents Keratosis Immunologic Factors Facies Skin Diseases Interferons Cyclooxygenase Inhibitors Adjuvants, Immunologic Disease Progression |
Diclofenac Imiquimod Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Tylosis |
Anti-Inflammatory Agents Interferon Inducers Keratosis Immunologic Factors Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Cyclooxygenase Inhibitors Physiological Effects of Drugs Adjuvants, Immunologic Diclofenac |
Enzyme Inhibitors Imiquimod Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |