Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

This is an interventional treatment trial for Seborrheic Keratosis (SK) focused on measuring SK, Seborrheic Keratosis Read More

Inclusion Criteria:

1. Is at least 18 years of age
2. Has a clinical diagnosis of stable clinically typical seborrheic keratosis
3. Has at least 4 appropriate seborrheic keratosis target lesions on the back
4. If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
5. Is non-pregnant and non-lactating
6. Is in good general health and free of any 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. Is willing and able to follow all study instructions and to attend all study visits
8. Is able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

1. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
2. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)

3. Has used any of the following systemic therapies within the specified period prior to Visit 1:

   • Retinoids; 180 days
   • Glucocorticosteroids; 28 days
   • Anti-metabolites (e.g., methotrexate); 28 days

4. Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:

   • Retinoids; 90 days
   • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
   • Glucocorticosteroids or antibiotics; 14 days
   • Moisturizers/emollients, sunscreens; 12 hours
5. Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
6. Has a history of keloid formation or hypertrophic scarring
7. Has a current systemic malignancy
8. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
9. Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
10. Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
11. Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
12. Has experienced a sunburn on the treatment area within the previous 4 weeks
13. Has a history of sensitivity to any of the ingredients in the study medications
14. Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
15. Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.