Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers (Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ)
Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.
‣ Subjects must meet all of the following criteria to be included in the study:
• Must be able to comprehend and willing to sign an informed consent form (ICF).
• Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information.
• Must be at least 18 years of age.
• Histologically confirmed seborrheic keratosis, basal cell skin cancer (superficial, nodular, and/or infiltrating subtype) and/or squamous cell carcinoma in situ from screening biopsies
• At least 1 and up to 5 screened and histologically confirmed eligible NMSC and/or SK lesions max between 0.5-2.0 cm in greatest tumor diameter
• NMSCs must also meet the following criteria:
• Primary tumor (no recurrent or previously treated tumors)
• Located on the scalp, face (excluding ears and nose), trunk, or extremities (excluding the hands and feet)
• Qualifies for standard surgical excision or Mohs micrographic surgery as primary therapy
• Not be on the eyelid or within 5 mm of the orbital rim
• SKs must also meet the following criteria
• PLA 2 (\<1 mm in thickness)
• Have one or more of the following dermoscopy features throughout the entirety of the lesion: crypts (comedo-like openings), milia cysts, hairpin vessels with white halo, fat sharp demarcation, blue-white pigmentation/veil as long as milia and crypts are present within, more than one color, cerebriform structure (gyri and sulci/network-like pattern/ridges and fissures/fat fingers), irregular vessels (inframammary only), granularity at periphery, stalactite/Tsingy pattern, plate-like/fractured pattern (Simionescu et al., 2012) (Note: SK lesions must NOT have any of the following features indicative of malignancy under dermoscopy: pinpoint vessels, smooth blue-white pigmentation/veil without milia or crypts within, hairpin vessels without white halo, white artifacts, irregular vessels (except for inframammary lesions). Additionally, SK lesions must not have a moth-eaten border or fingerprint structures indicative of lentigos or a network pattern indicative of a melanocytic lesion)
• Located on the scalp, face (including ears), trunk, intertriginous areas, or extremities
• Not be on the eyelid or within 5 mm of the orbital rim
• Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any treated lesion or which exposes the subject to an unacceptable risk by study participation.
• Must be willing and able to follow all study instructions and to attend all study visits.
⁃ Technical ability to apply treatment to all enrolled lesion
⁃ Must be willing to have all lesions removed surgically by either Mohs micrographic surgery or standard excision for NMSCs or shave excision for SKs at the final 2-week follow up visit.