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SM-020 Gel for Dermatosis Papulosa Nigra

Q: What potential risks are posed to patients by SM-020 gel 1.0%?

The risk assessment of SM-020 gel 1.0% was assessed as a 2, due to its Phase 2 designation which suggests the presence of preliminary safety data but lacking evidence in terms of efficacy.

Q: What is the current capacity for enrollees in this research endeavor?

Affirmative, clinicaltrials.gov suggests that the trial is still recruiting participants since it was posted on October 23rd 2023 and last modified on October 25th 2023. Ten patients must be recruited from one medical facility for this study to continue its progress.

Q: Are there currently any openings to join this research endeavor?

Yes, according to the information on clinicaltrials.gov, enrollment is currently open for this medical trial which was initially announced on October 23rd 2023 and last updated on October 25th 2023. A total of 10 patients are needed from one site.

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

DPNTLs must have a diameter that is ≥2mm but ≤5mm

DPNTLs must have one or more clinical features throughout the entirety of the lesion: clustered, small (<5mm), waxy, warty, stuck-on, sharply demarcated, tan to black papules, milia-like cysts, on the cheeks and temples in people of color, particularly of African or Asian descent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through week 16

Awards & highlights

Study Summary

This trial will explore the safety & effectiveness of a gel to treat Dermatosis Papulosa Nigra, a common skin condition with 5-10 affected areas per person. Subjects apply the gel twice daily for 4 weeks, then monitored for 12 weeks.

Who is the study for?

Adults over 18 with Dermatosis Papulosa Nigra (DPN), specifically those with skin types 4, 5, or 6. Participants must have at least five but no more than ten eligible DPN lesions on the face that are not inflamed or covered by hair and are between 2mm to 5mm in diameter. Pregnant women, individuals using certain medications like immunosuppressives or photosensitizers, and those with a history of skin cancer near the lesions cannot participate.Check my eligibility

What is being tested?

The trial is testing SM-020 gel at a concentration of 1.0% for safety and effectiveness in treating DPN. Around ten participants will apply this gel twice daily for four weeks to up to ten selected facial lesions. They'll be monitored for twelve additional weeks after treatment ends.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include local skin reactions such as irritation, redness, itching or burning sensation where the gel is applied due to sensitivity to its ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My skin lesions are between 2mm and 5mm in size.

Select...

My skin lesions are small, waxy, and match the description for people of African or Asian descent.

Select...

My skin lesions are not close to the edge of my eye socket.

Select...

I agree to have any partially treated skin lesions surgically removed.

Select...

My skin growths are not attached by a narrow stalk.

Select...

My skin lesions are not red, sore, or scratched.

Select...

I am over 18 and can sign the consent form.

Select...

My skin growths are not on my eyelids.

Select...

I have up to 10 treatable skin lesions.

Select...

I have been diagnosed with Dermatosis Papulosa Nigra.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 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

Assessment of the severity of the Application Site Reactions and review of adverse events

Proportion of all DPNTLs that achieve clearance (DPNLA score of 0)

Secondary outcome measures

Assess superiority of active over vehicle as measured by the subject satisfaction assessment score for their DPNTLs at week 16

Comparison of % clearance of DPNTLs at week 16 to onset, frequency, and severity of Application Site Reactions (ASRs)

Comparison of % clearance of DPNTLs at week 16 to subject satisfaction assessment score

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SM-020 gel 1.0%Experimental Treatment1 Intervention

Subjects will apply the investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12 weeks post final application for a total of approximately 16 weeks of required participation in the study.

0 / 10Eligibility criteria met

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Who is running the clinical trial?

DermBiont, Inc.Lead Sponsor

11 Previous Clinical Trials

543 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks are posed to patients by SM-020 gel 1.0%?

"The risk assessment of SM-020 gel 1.0% was assessed as a 2, due to its Phase 2 designation which suggests the presence of preliminary safety data but lacking evidence in terms of efficacy."

Answered by AI

What is the current capacity for enrollees in this research endeavor?

"Affirmative, clinicaltrials.gov suggests that the trial is still recruiting participants since it was posted on October 23rd 2023 and last modified on October 25th 2023. Ten patients must be recruited from one medical facility for this study to continue its progress."

Answered by AI

Are there currently any openings to join this research endeavor?

"Yes, according to the information on clinicaltrials.gov, enrollment is currently open for this medical trial which was initially announced on October 23rd 2023 and last updated on October 25th 2023. A total of 10 patients are needed from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra (DPN)

2023. "A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra (DPN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099080.

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