Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA)
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ClinicalTrials.gov Identifier: NCT00777127 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : February 1, 2013
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Sponsor:
MEDA Pharma GmbH & Co. KG
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
Tracking Information | |||||||
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First Submitted Date ICMJE | October 21, 2008 | ||||||
First Posted Date ICMJE | October 22, 2008 | ||||||
Last Update Posted Date | February 1, 2013 | ||||||
Study Start Date ICMJE | December 2008 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Recurrence with respect to the study treatment area until month 12 [ Time Frame: week 20 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
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Original Primary Outcome Measures ICMJE |
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 ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses | ||||||
Official Title ICMJE | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Actinic Keratosis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
258 | ||||||
Original Estimated Enrollment ICMJE |
240 | ||||||
Actual Study Completion Date ICMJE | November 2012 | ||||||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Safety concerns:
Lack of suitability for the study:
Administrative reasons:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Austria, France, Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00777127 | ||||||
Other Study ID Numbers ICMJE | X-03016-3271 2007-004884-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | MEDA Pharma GmbH & Co. KG | ||||||
Study Sponsor ICMJE | MEDA Pharma GmbH & Co. KG | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | MEDA Pharma GmbH & Co. KG | ||||||
Verification Date | January 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |