Actinic Keratosis Clinical Trial
Official title:
An Open-label, Multiple-dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis
The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.
It is an open-label, multiple-dose, pharmacokinetic study. In stage 1, plasma concentration
of solamargine will be examined after the test products were administrated to 5 subjects with
Actinic Keratosis (AK). Thereafter, an interim report based on the results of stage 1 will be
submitted for Taiwan Center for Drug Evaluation (CDE) review to determine stage 2 will be
conducted or not. For stage 2, another 5 subjects with AK will be enrolled to complete the
study.
The subjects will be recruited from AK patients of Taiwan. All subjects will sign an informed
consent form (ICF). A copy of the signed ICF will be handed to the subjects. The subjects
will be screened on an outpatient basis within 1 month prior to entry according to defined
inclusion and exclusion criteria (medical history, personal history, physical examination,
and laboratory values). The subject must be qualified for the study by fulfilling all of the
inclusion and none of the exclusion criteria.
In the study period, study drug will be given once daily for sixteen consecutive weeks.
Specifically, subjects will receive a single dose of 0.3-0.5 g topical SR-T100 gel
(containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by
occlusive dressing at least 20 hours a day.
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