A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses… (NCT06409195) | Clinical Trial Compass
UnknownPhase 2
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers
United States50 participantsStarted 2024-03-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of lesions that achieve a 50% reduction in greatest diameter of cohort-assigned TL(s) at week 6 compared to baseline
Timeframe: At week 6
2
Safety and Tolerability will be evaluated through assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs)
. 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.
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.
. SK lesions that are clinically atypical and/or rapidly growing in size or number.
. Presence of multiple eruptive SK lesions (sign of Leser-Trelat)
. Current systemic malignancy.
. Past history of lymphoproliferative disorder
. Any use of the following systemic therapies within the specified period prior to the Baseline visit and while on study:
. Any use of the following topical therapies within the specified period prior to the Baseline visit and while on study on or in a close proximity to any treated lesion (TL) that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
. Occurrence or presence of any of the following within the specified period prior to the Baseline visit on or in the proximity of any TL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments: