Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With … (NCT05136144) | Clinical Trial Compass
UnknownPhase 2
Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
El Salvador70 participantsStarted 2021-10-19
Plain-language summary
This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.
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).
✓. At least 18 years of age.
✓. Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 will be targeted for treatment. There will be a maximum of 5 PLA 2's per subject. An eligible SKTL must each:
✓. Have one or more of the following clinical features throughout the entirety of the lesion consistent with SKs: stuck-on, warty, waxy, scaly, milia-like cyst, tan to black
✓. For subjects randomized for assessment with clinical diagnosis and dermoscopy, SKs must also have one or more of the dermoscopy features throughout the entirety of the lesion: moth-eaten border, fingerprinting structures, network-like pattern, network pattern, crypts (comedo-like openings), milia cysts, pinpoint vessels, hairpin vessels, fat fingers, sharp demarcation, blue-white pigmentation, more than one color, cerebriform structure, irregular, polymorphic pattern, fissures, white artefacts, irregular vessels (Simionescu et al., 2012).
✓. Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm) or 3 (a thickness that is \>1mm)
✓. Have a greatest diameter that is ≥5mm and ≤15mm
✓. Be a discrete, well-defined, separate lesion
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 for the duration of the study.
What they're measuring
1
Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%
Timeframe: Through 20 weeks
2
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%
Timeframe: Through 20 weeks
3
Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%
. SK lesions that are clinically atypical and/or rapidly growing in size.
✕. 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:
✕. Retinoids; 180 days
✕. Glucocorticosteroids; 28 days
✕. Anti-metabolites (e.g., methotrexate); 28 days