Randomized Double-Blind Vehicle-Controlled Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
The objective of the trial is to evaluate the safety and efficacy of SM-020 gel 1.0% in subjects with Seborrheic Keratosis (SK) compared to vehicle gel. It is a randomized, double-blind, vehicle-controlled trial. Approximately 60 subjects will be enrolled. Subjects will apply their assigned investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12-weeks post final application for a total of approximately 16-weeks of required participation in the study.
∙ 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.
• Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 SKTLs will be targeted for treatment. An eligible SKTL must :
‣ Have one or more of the following clinical features throughout the entirety of the lesion consistent with SKs: stuck-on, sharply demarcated, warty, waxy, scaly, milia-like cyst, tan to black
⁃ For subjects randomized for eligibility assessment with dermoscopy, SKs must also 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, sharp demarcation, blue-white pigmentation/veil as long as milia and crypts are present within, more than one color, cerebriform structure (network-like pattern/gyri and sulci/ridges and fissures/fat fingers), irregular vessels (inframammary only), granularity at periphery, stalactite/Tsingy pattern, plate-like/fractured pattern (Simionescu et al., 2012)
⁃ Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm)
⁃ Have a greatest diameter that is \>5mm but ≤15mm
⁃ Be a discrete, well-defined, separate lesion
⁃ Not be covered with hair which, in the Investigator's opinion, would interfere with the study gel treatment or the study evaluations
⁃ Not be pedunculated
⁃ Not be on the eyelid
⁃ Not be within 5mm 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 SKTL 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.
• Must be willing to have all partial, incompletely, or non-responding SKTLs removed surgically by shave excision during the final visit.