SYF890968076700479297e7195ba7ce8193Registry ID: 2024-515667-60-00|Active Not RecruitingPhase 2
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interventional
N/A
1 country
5
To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2024
Actual (reported)Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.
1. Partial and complete clearance rate of AK lesions at the end of first and second cycles: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).
2. Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire.
3. Evaluation of adherence by Treatment Adherence Questionnaire.
4. Rate of subjects who complete one treatment cycle.
5. Rate of subjects who complete two treatment cycles.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
ALDARA 5% cream
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CREAM
View registry recordFormulated product
Keramod® gel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
ALDARA 5% cream
Named ingredient: Imiquimod
View registry recordKeramod® gel
Named ingredient: Imiquimod
View registry recordFundacion Instituto Valenciano De Oncologia
Valencia, 46009, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Universitario Virgen De Las Nieves
Granada, 18014, Spain
Clinical Development Manager
First Submitted
September 16, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
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Hospital De La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain