A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis (NCT06108024) | Clinical Trial Compass
RecruitingPhase 2
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
United States60 participantsStarted 2023-11-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control (such as oral contraceptive pills (OCPs), Intrauterine devices (IUDs), birth control implants, vaginal rings, or injections) for the duration of the study.
What they're measuring
1
Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0
Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic Keratosis
Timeframe: Through week 16 (Visit 9)
3
Safety and Tolerability as evaluated by review of adverse events
✕. SK lesions that are clinically atypical and/or rapidly growing in size or number.
✕. SK lesions that 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, for lesions randomized to dermoscopy, SK lesions must not have a moth-eaten border or fingerprint structures indicative of lentigos or a network pattern indicative of a melanocytic lesion.
✕. Presence of multiple eruptive SK lesions (sign of Leser-Trelat).
✕. Current systemic malignancy.
✕. Any use of the following systemic therapies within the specified period, or unwilling to meet the following washouts, prior to the Baseline visit and while on study: