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| Sponsor: | MEDA Pharma GmbH & Co. KG |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
|
Active Comparator: 2
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 | |
| Hospital Feldkirch, Department for Dermatology and Venereology | |
| Feldkirch, Austria, A-6807 | |
| Medical University Graz, University Clinic for Dermatology and Venereology | |
| Graz, Austria, A-8036 | |
| Medical University Innsbruck, University Clinic for Dermatology and Venereology | |
| Innsbruck, Austria, A-6020 | |
| Medical University Vienna, Department for General Dermatology | |
| Vienna, Austria, A-1090 | |
| France | |
| CHU St Jacques, Department for Dermatology | |
| Besancon Cedex, France, F-25030 | |
| Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor | |
| Marseille, France, F-13009 | |
| CHU Nice - Hospital Archet 2, Department for Dermatology | |
| Nice, France, F-06202 | |
| Hospital Saint-Louis, Derpartment for Dermatology | |
| Paris, France, F-75010 | |
| Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology | |
| Pierre Benite, France, F-69495 | |
| Germany | |
| Licca Clinical Research Institute | |
| Augsburg, Germany, D-86179 | |
| Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology | |
| Berlin, Germany, D-10117 | |
| Medical Practice Dominicus / Bockhorst | |
| Duelmen, Germany, D-48249 | |
| Medical practice | |
| Düsseldorf, Germany, D-40210 | |
| University Clinic Düsseldorf, Clinic for Dermatology | |
| Düsseldorf, Germany, D-40255 | |
| Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology | |
| Frankfurt am Main, Germany, D-60590 | |
| SCiderm GmbH | |
| Hamburg, Germany, D-20354 | |
| Medical Practice | |
| Hannover, Germany, D-30159 | |
| University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology | |
| Kiel, Germany, D-24105 | |
| Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology | |
| Magdeburg, Germany, D-39120 | |
| Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center | |
| Mainz, Germany, D-55131 | |
| 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 | |
| Clinic University Regensburg, Clinic and Polyclinic for Dermatology | |
| Regensburg, Germany, D-93053 | |
| Derma Center Vechta | |
| Vechta, Germany, D-49377 | |
| Centrovital | |
| Witten, Germany, D-58453 | |
| Medical practice for Dermatology and Venerology | |
| Wuppertal, Germany, D-42275 | |
| 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: | MEDA Pharma GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00777127 History of Changes |
| Other Study ID Numbers: | X-03016-3271, 2007-004884-24 |
| Study First Received: | October 21, 2008 |
| Last Updated: | October 7, 2011 |
| 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 |
|
Keratosis Keratosis, Actinic Ichthyosis Keratoacanthoma Skin Diseases Precancerous Conditions Neoplasms Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases Diclofenac Imiquimod Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Adjuvants, Immunologic Immunologic Factors Antineoplastic Agents Interferon Inducers |