SM-020 Gel for Seborrheic Keratosis

Recruiting at 3 trial locations

Overseen By Phoebe Rich, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: DermBiont, Inc.

Must not be taking: Retinoids, Chemotherapy, Immunosuppressives, others

Disqualifiers: Pregnancy, Systemic malignancy, Skin disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel, SM-020, to determine its safety and effectiveness in treating seborrheic keratosis, which are non-cancerous skin growths resembling warts or waxy spots. Participants will apply either the SM-020 gel or a placebo gel (a look-alike with no active ingredient) twice daily for four weeks. The trial seeks individuals with 5 to 10 skin spots that meet specific criteria, such as being tan to black in color and not covered with hair. Participants will be monitored for 16 weeks to assess the treatment's effectiveness and any side effects. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting. If you're taking retinoids, chemotherapy, or vismodegib, you need to stop 180 days before the trial. Other medications like immunosuppressive therapy, biologics, glucocorticosteroids, and known photosensitizing medications need to be stopped 28 days before.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SM-020 gel 1.0% is generally safe to use. In earlier studies, people using the gel for seborrheic keratosis (a common, non-cancerous skin growth) experienced only mild side effects, indicating that most did not have serious reactions to the gel.

These results are promising and suggest the gel is safe for people. However, since the trial is still ongoing, further testing will help confirm these findings. Overall, current evidence indicates that SM-020 gel is a safe option for treating seborrheic keratosis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Seborrheic Keratosis?

Unlike most treatments for seborrheic keratosis, which typically involve freezing, scraping, or laser treatments, SM-020 gel is a topical solution applied directly to the skin. Researchers are excited about SM-020 because it offers a non-invasive alternative that can be used safely at home, reducing the need for clinical procedures. Plus, its unique formulation is designed to target and break down the lesions effectively over a short treatment period of just 28 days. This could represent a significant shift towards more convenient and accessible care for those dealing with this common skin condition.

What evidence suggests that SM-020 gel might be an effective treatment for Seborrheic Keratosis?

Research has shown that SM-020 gel 1.0%, which participants in this trial may receive, may help treat seborrheic keratosis (SK), a common skin condition. In one study, over 80% of SK spots treated with SM-020 gel improved by at least one level on a standard scale after 14 to 28 days. This suggests the gel could effectively treat SK. Reports also indicate it is safe and easy to use. These findings offer hope for those seeking new SK treatments. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The size of the thing we're looking at must be bigger than 5mm but not bigger than 15mm.

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

Exclusion Criteria

I have multiple sudden skin growths.

My skin lesions are unusual or growing quickly.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants apply the assigned investigational product twice daily for 4 consecutive weeks

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Bi-weekly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SM-020 gel 1.0%
• Vehicle gel

Trial Overview 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.

How Is the Trial Designed?

Group I: SM-020 gel 1.0% Active Control 1 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 gel Placebo Group 1 Intervention

Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.

Who Is Running the Clinical Trial?

DermBiont, Inc.

Lead Sponsor

Trials

14

Recruited

740+

Citations

1. dermbiont.com dermbiont.com/in-the-news/2023/3/22/dermbiont-presents-positive-phase-2-trial-data-treating-seborrheic-keratosis-with-sm-020-topical-gel-at-american-academy-of-dermatology-annual-meeting

DermBiont Presents Positive Phase 2 Trial Data Treating ... We believe that SM-020 has the potential to provide patients with a safe, well-tolerated, and easy to apply product to treat their SK lesions at ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06108024

A Trial to Evaluate the Safety and Efficacy of SM-020 Gel ... 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.

3. practicaldermatology.com practicaldermatology.com/news/take-that-sks-dermbionts-sm-020-topical-gel-performs-well-in-phase-2-study/2461623/

Take That SKs! DermBiont's SM-020 Topical Gel Performs ... More than 80% of seborrheic keratosis (SK) lesions treated for 14 to 28 days with DermBiont's SM-020 gel 1.0% had at least a one-point improvement in Physician ...

4. dermbiont.com dermbiont.com/in-the-news/2024/2/22/dermbiont-announces-2024-development-pipeline-update-for-its-first-in-class-targeted-topical-therapeutics-for-seborrheic-keratoses-basal-cell-carcinomas-and-melasma

DermBiont Announces 2024 Development Pipeline Update ... “The data we have generated to date treating SKs with SM-020 gel 1.0% is highly encouraging, providing a safe and effective treatment option for ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/483056

A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in ... 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 ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0116301

Seborrheic Keratosis (SK) (DBCOND0116301) A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis. SM-020. treatment, 2, recruiting. NCT02160626. Dose- ...