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Tracking Information | |||||||||
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First Received Date † | October 21, 2008 | ||||||||
Last Updated Date | April 7, 2009 | ||||||||
Start Date † | December 2008 | ||||||||
Current Primary Outcome Measures † |
a) Primary Endpoint: Recurrence with respect to the study treatment area. 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. [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00777127 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Long-Term Effects of Imiquimod and Diclofenac in Actinic Keratoses | ||||||||
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) | ||||||||
Brief Summary | 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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Detailed Description | |||||||||
Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Actinic Keratosis | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 240 | ||||||||
Estimated Completion Date | April 2012 | ||||||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: Safety concerns:
Lack of suitability for the study:
Administrative reasons:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Austria, France, Germany | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00777127 | ||||||||
Responsible Party | Dr. Joachim Maus / Director, Clinical Development, n.a. | ||||||||
Secondary IDs †† | EudraCT:2007-004884-24 | ||||||||
Study Sponsor † | MEDA Pharma GmbH & Co. KG | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | MEDA Pharma GmbH & Co. KG | ||||||||
Verification Date | April 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |