A Randomized, Double-Blind, Vehicle Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis.
A Randomized, Double-Blind, Vehicle Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis.
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.
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Each subject will have 4 target lesions on the trunk/extremities.
A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.
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).
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 a current systemic malignancy
Subject has a history of keloid formation or hypertrophic scarring
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
Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.