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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004884-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Aldara 5% Cream |
|
| 2 | Active Comparator | Solaraze 3% Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence with respect to the study treatment area until month 12 | A patient is classified as recurrent when cleared at Visit Week 20 and having later on at least one clinically diagnosed AK lesion in the study treatment area | week 20 until month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence | 3 years | |
| Long-term outcome with respect to development of SCC (in situ and/or invasive) | 3 years | |
| Need of rescue treatment |
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Inclusion Criteria:
Exclusion Criteria:
Safety concerns:
Lack of suitability for the study:
Administrative reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Gollnick, MD, Prof. | Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology | Principal Investigator |
| Ursula Petzold, PhD | MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Feldkirch, Department for Dermatology and Venereology | Feldkirch | A-6807 | Austria | |||
| Medical University Graz, University Clinic for Dermatology and Venereology |
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| Label | URL |
|---|---|
| European Dermatology Forum, Guidelines for the management of actinic keratoses. Last modified 26 Ocotober 2006. | View source |
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|
| Diclofenac | Drug | 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. |
|
| 3 years |
| Haematological changes | 20 weeks |
| Cosmetic outcome. | 3 years |
| Graz |
| A-8036 |
| Austria |
| Medical University Innsbruck, University Clinic for Dermatology and Venereology | Innsbruck | A-6020 | Austria |
| Medical University Vienna, Department for General Dermatology | Vienna | A-1090 | Austria |
| CHU St Jacques, Department for Dermatology | Besançon | F-25030 | France |
| Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor | Marseille | F-13009 | France |
| CHU Nice - Hospital Archet 2, Department for Dermatology | Nice | F-06202 | France |
| Hospital Saint-Louis, Derpartment for Dermatology | Paris | F-75010 | France |
| Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology | Pierre-Bénite | F-69495 | France |
| Licca Clinical Research Institute | Augsburg | D-86179 | Germany |
| Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology | Berlin | D-10117 | Germany |
| Medical Practice Dominicus / Bockhorst | Dülmen | D-48249 | Germany |
| Medical practice | Düsseldorf | D-40210 | Germany |
| University Clinic Düsseldorf, Clinic for Dermatology | Düsseldorf | D-40255 | Germany |
| Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology | Frankfurt am Main | D-60590 | Germany |
| SCiderm GmbH | Hamburg | D-20354 | Germany |
| Medical Practice | Hanover | D-30159 | Germany |
| University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology | Kiel | D-24105 | Germany |
| Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology | Magdeburg | D-39120 | Germany |
| Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center | Mainz | D-55131 | Germany |
| Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics | Mönchengladbach | D-41061 | Germany |
| University Clinic Münster, Clinic and Polyclinic for Skin Diseases | Münster | D-48149 | Germany |
| Clinic University Regensburg, Clinic and Polyclinic for Dermatology | Regensburg | D-93053 | Germany |
| Derma Center Vechta | Vechta | D-49377 | Germany |
| Centrovital | Witten | D-58453 | Germany |
| Medical practice for Dermatology and Venerology | Wuppertal | D-42275 | Germany |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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