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SM-020 Gel for Seborrheic Keratosis

Phase 2
Waitlist Available
Research Sponsored by DermBiont, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs
Must not be within 5mm of the orbital rim
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 16
Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of SM-020 gel 1.0% for treating Seborrheic Keratosis. 60 people will apply the product twice daily for 4 weeks and be monitored for 16 weeks total.

Who is the study for?
This trial is for adults with Seborrheic Keratosis who have at least 5 affected areas not on eyelids or covered by hair. Participants must understand and sign consent forms, be free of certain diseases, agree to follow study instructions, and attend all visits. Pregnant women or those not using birth control are excluded.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of SM-020 gel (1%) compared to a placebo gel in treating Seborrheic Keratosis. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment. The gel is applied twice daily for four weeks with a follow-up period of twelve weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include skin irritation at the application site such as redness, itching or burning sensation, dryness or peeling skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 5 treatable skin lesions on my face, body, or limbs.
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My condition is not within 5mm of the eye socket edge.
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I am 18 years old or older.
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My cancer is a single, clearly defined tumor.
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I agree to have any non-responding skin lesions surgically removed.
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My condition does not affect my eyelid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability as evaluated by assessment of the severity of the signs and symptoms of Application Site Reactions (ASRs) of Seborrheic Keratosis
Safety and Tolerability as evaluated by review of adverse events
Superiority of active over vehicle as measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve a PLA score of 0
Secondary outcome measures
Superiority of active over vehicle as measured by the percent recurrence of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a PLA of 0 or 1
Superiority of active over vehicle as measured by the percentage of all SKTLs, facial SKTLs, truncal SKTLs, intertriginous SKTLs, and extremity SKTLs with a SSA (Subject's Self-Assessment) of 0 or 1
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SM-020 gel 1.0%Active Control1 Intervention
SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.
Group II: Vehicle gelPlacebo Group1 Intervention
Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.

Find a Location

Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor
11 Previous Clinical Trials
493 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SM-020 gel 1.0% been given the green light by the FDA?

"With limited evidence of efficacy, the SM-020 gel 1.0% was assigned a score of 2 on our safety scale due to existing data indicating at least some level of security."

Answered by AI

Are there any open slots available to participate in this clinical trial?

"Yes, the available clinical information indicates that this experiment is actively recruiting. First posted on October 23rd 2023 and edited most recently on October 25th 2023, 60 subjects are needed from 1 medical facility."

Answered by AI

What is the current patient cohort size of this research project?

"Affirmative. The website clinicaltrials.gov indicates that this medical research, which was announced on October 23rd 2023, is currently searching for individuals to participate. Approximately 60 people must be enrolled at a single trial centre."

Answered by AI

Who else is applying?

What site did they apply to?
Oregon Medical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I want to see if something can help with my SK's. Nothing to this date has been able to.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
2023. "A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108024.
All > Vancouver > Actinic Keratosis
~9 spots leftby Jun 2024
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