In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation. The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
cutaneous use twice a day
Unnamed facility
Blaubeuren Abbey, Germany
Unnamed facility
Friedrichshafen, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Langenau, Germany
Change of skin alterations during treatment period
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Change of visible skin alterations during treatment period
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Tolerability of the investigated medicinal product
Tolerability will be assessed on the basis of adverse events
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Adverse events
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
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Unnamed facility
Radolfzell, Germany
Unnamed facility
Stuttgart, Germany
Unnamed facility
Stuttgart, Germany
Unnamed facility
Stuttgart, Germany
Unnamed facility
Tübingen, Germany