Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis (NCT02160626) | Clinical Trial Compass
CompletedPhase 2
Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis
United States172 participantsStarted 2014-06
Plain-language summary
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is at least 18 years of age
✓. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
✓. Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:
✓. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study
✓. Subject is non-pregnant and non-lactating
✓. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation
✓. Subject is willing and able to follow all study instructions and to attend all study visits
✓. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF).
✕. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
✕. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments:
✕. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments:
✕. Subject has a history of sensitivity to any of the ingredients in the study medications