What side effects are associated with this type of intervention?

Common side effects of topical treatments for Seborrheic Keratosis, such as hydrogen peroxide and trichloroacetic acid, include skin irritation, redness, swelling, and a burning sensation at the application site. In some cases, patients may experience blistering, peeling, or changes in skin pigmentation. These side effects are generally mild and temporary but should be discussed with a healthcare provider.

What prior FDA approvals exist?

As of now, there are limited FDA-approved topical treatments specifically for Seborrheic Keratosis. One notable FDA-approved treatment is hydrogen peroxide 40% topical solution (Eskata), which is used to treat raised Seborrheic Keratosis. This treatment involves the application of a high-concentration hydrogen peroxide solution directly to the lesions. Other treatments for Seborrheic Keratosis typically include cryotherapy, curettage, and laser therapy, but these are procedural rather than topical treatments. The trial of SM-020 gel 1.0% represents an effort to expand the options for topical treatments for this condition.

What other types of research exist?

Promising novel alternatives to SM-020 gel 1.0% for Seborrheic Keratosis patients in 2024 include: 1) Topical hydrogen peroxide 40% solution, which has shown efficacy in clearing SK lesions. 2) A-101 40% topical solution, which is a high-concentration hydrogen peroxide solution specifically formulated for SK. 3) Laser treatments, such as fractional CO2 laser, which have been effective in reducing SK lesions with minimal side effects. Patients should discuss these options with their dermatologist to determine the best treatment plan.

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SM-020 Gel for Seborrheic Keratosis

Phase 2

Recruiting

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

Must not have

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

SK lesions that are clinically atypical and/or rapidly growing in size or number

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

Summary

This trial is testing a special gel called SM-020 to see if it can safely and effectively treat Seborrheic Keratosis, a common skin condition. Patients will apply the gel regularly for a few weeks. The goal is to see if the gel can reduce or eliminate the skin growths.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I agree to use birth control during the study.

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My skin lesions are unusual or growing quickly.

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My skin lesions look cancerous under a special skin exam.

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I have multiple sudden skin growths.

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I have cancer that is spreading in my body.

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I haven't taken certain medications before starting this study.

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I have had specific health issues near my skin lesion recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 16

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

+4 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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Seborrheic Keratosis (SK) include topical agents that work by promoting the shedding of the outer skin layer, reducing cell proliferation, or inducing cell death in the abnormal keratinocytes. For example, topical treatments like SM-020 gel 1.0% may contain active ingredients that help to break down the keratin in SK lesions, leading to their gradual reduction. This is important for SK patients as it offers a non-invasive option to manage and reduce the appearance of lesions, potentially improving cosmetic outcomes and patient comfort without the need for surgical interventions.

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