A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Intervention: A-101 Solution; Vehicle Solution
Intervention description: Placebo
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 487.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: seborrheic keratosis

Summary:

      This is a randomized, double-blind, vehicle-controlled, parallel group study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is at least 18 years of age

          2. Clinical diagnosis of stable clinically typical seborrheic keratosis

          3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk,
             extremities and face that each are eligible for treatment as defined below:

               -  Have a clinically typical appearance

               -  Have a PLA of 2 or greater and be a discrete lesion

               -  Not be covered with hair which, in the investigator's opinion, would interfere
                  with the study medication treatment or the study evaluations

               -  Not be in an intertriginous fold

               -  Not be on the eyelids

               -  Not be within 5mm of the orbital rim

               -  Not be pedunculated

          4. If the subject is a woman of childbearing potential, she has a negative urine
             pregnancy test and agrees to use an active method of birth control for the duration of
             the study

          5. Subject is non-pregnant and non-lactating

          6. 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

          7. Subject is willing and able to follow all study instructions and to attend all study
             visits

          8. Subject is able to comprehend and willing to sign an Informed Consent Form.

        Exclusion Criteria:

        1. Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions 2.
        Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser
        -Trelat) 3. Subject has a current systemic malignancy 4. Subject has used any of the
        following systemic therapies within the specified period prior to enrollment:

          -  Retinoids; 180 days

          -  Glucocortico-steroids;

          -  Anti-metabolites (e.g., methotrexate); 5. Subject has used any of the following
             topical therapies within the specified period or in a proximity to any Target Lesion,
             that in the investigator's opinion interferes with the study medication treatment or
             the study assessments:

          -  LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic
             therapy;

          -  Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol
             mebutate;

          -  Retinoids;

          -  Microdermabrasion or superficial chemical peels;

          -  Glucocortico-steroids or antibiotics 6. Subject currently has or has had any of the
             following within the specified period or in a proximity to any Target Lesion that, in
             the investigator's opinion, interferes with the study medication treatment or the
             study assessments:

          -  A cutaneous malignancy;

          -  A sunburn; currently

          -  A pre-malignancy (e.g., actinic keratosis); currently

          -  Body art (e.g., tattoos, piercing, etc.); currently

          -  Excessive tan; currently 7. Subject has a history of sensitivity to any of the
             ingredients in the study medications 8. 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 9. Subject has participated in an investigational drug trial in which
             administration of an investigational study medication occurred within 30 days prior to
             enrollment.