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 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.

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.

How does the SM-020 gel drug for seborrheic keratosis differ from other treatments?

The SM-020 gel for seborrheic keratosis is unique because it is specifically formulated as a 1.0% gel, which may offer a novel approach compared to other treatments like dobesilate cream or ingenol mebutate gel used for similar skin conditions. Unlike traditional treatments that may focus on antifungal or anti-inflammatory properties, SM-020 gel's specific formulation and concentration could provide a new mechanism or benefit for treating seborrheic keratosis. ^{1 2 3 4 5}

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. United States pubmed.ncbi.nlm.nih.gov

Ketoconazole gel 2% in the treatment of moderate to severe seborrheic dermatitis. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Topical application of nanoparticles integrated supramolecular hydrogels for the potential treatment of seborrhoeic dermatitis. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of seborrhoeic eczema with ketoconazole in comparison with an active agent-free cream]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Clearance of seborrhoeic keratoses with topical dobesilate. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Reduced degree of irritation during a second cycle of ingenol mebutate gel 0.015% for the treatment of actinic keratosis. [2016]