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| Sponsor: | MEDA Pharma GmbH & Co. KG |
|---|---|
| Information provided by: | MEDA Pharma GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00777127 |
Purpose
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 |
|---|---|---|
|
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) |
| Enrollment: | 258 |
| 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 |
|---|---|
|
1: Experimental
Aldara 5% Cream
|
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.
|
|
2: Active Comparator
Solaraze 3% Gel
|
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.
|
Eligibility| 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:
Contacts and Locations| Austria | |
| Medical University Vienna, Department for General Dermatology | |
| Vienna, Austria, A-1090 | |
| Medical University Innsbruck, University Clinic for Dermatology and Venereology | |
| Innsbruck, Austria, A-6020 | |
| Hospital Feldkirch, Department for Dermatology and Venereology | |
| Feldkirch, Austria, A-6807 | |
| Medical University Graz, University Clinic for Dermatology and Venereology | |
| Graz, Austria, A-8036 | |
| France | |
| CHU Nice - Hospital Archet 2, Department for Dermatology | |
| Nice, France, F-06202 | |
| Hospital Saint-Louis, Derpartment for Dermatology | |
| Paris, France, F-75010 | |
| CHU St Jacques, Department for Dermatology | |
| Besancon Cedex, France, F-25030 | |
| Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology | |
| Pierre Benite, France, F-69495 | |
| Hospital Tenon, Department for Dermatology | |
| Paris, France, F-75020 | |
| Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor | |
| Marseille, France, F-13009 | |
| Germany | |
| Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology | |
| Magdeburg, Germany, D-39120 | |
| Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology | |
| Berlin, Germany, D-10117 | |
| SCiderm GmbH | |
| Hamburg, Germany, D-20354 | |
| Medical Practice Dominicus / Bockhorst | |
| Duelmen, Germany, D-48249 | |
| Medical practice | |
| Düsseldorf, Germany, D-40210 | |
| Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics | |
| Mönchengladbach, Germany, D-41061 | |
| University Clinic Münster, Clinic and Polyclinic for Skin Diseases | |
| Münster, Germany, D-48149 | |
| Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center | |
| Mainz, Germany, D-55131 | |
| Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology | |
| Frankfurt Am Main, Germany, D-60590 | |
| Clinic University Regensburg, Clinic and Polyclinic for Dermatology | |
| Regensburg, Germany, D-93053 | |
| University Clinic Düsseldorf, Clinic for Dermatology | |
| Düsseldorf, Germany, D-40255 | |
| Centrovital | |
| Witten, Germany, D-58453 | |
| Derma Center Vechta | |
| Vechta, Germany, D-49377 | |
| Medical practice for Dermatology and Venerology | |
| Wuppertal, Germany, D-42275 | |
| Licca Clinical Research Institute | |
| Augsburg, Germany, D-86179 | |
| Medical Practice | |
| Hannover, Germany, D-30159 | |
| University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology | |
| Kiel, Germany, D-24105 | |
| 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 |
More Information
| 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: | December 1, 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 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 |