A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrhe… (NCT03148691) | Clinical Trial Compass
CompletedPhase 2
A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
United States253 participantsStarted 2017-05-17
Plain-language summary
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
✓. Male or female ≥ 18 years old.
✓. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
✓. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:
✓. Have a clinically typical appearance
✓. Have a Physician's Lesion Assessment of ≥ 2
✓. Length that is ≥ 5mm and ≤ 15mm
✓. Width that is ≥ 5mm and ≤ 15 mm
Exclusion criteria
✕. Subject has clinically atypical and /or rapidly growing seborrheic keratosis lesions.
✕. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser - Trelat).
✕. Subject has current systemic malignancy.
✕. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
✕
What they're measuring
1
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
✕. Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.
✕. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
✕. Subject has a history of sensitivity to any of the ingredients in the study medications.