SM-020 Gel for Dermatosis Papulosa Nigra
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gel treatment, SM-020 gel 1.0%, designed to help individuals with Dermatosis Papulosa Nigra (DPN), a skin condition causing small, dark bumps. The trial will evaluate the gel's safety and effectiveness when applied twice daily for four weeks, with participants monitored for a total of 16 weeks. Suitable candidates include those with a clinical diagnosis of DPN, having 5 to 10 bumps between 2mm and 5mm in diameter, particularly those with skin types common in individuals of African or Asian descent. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) for various drugs, such as retinoids, chemotherapy, and immunosuppressive therapies, ranging from 14 to 180 days before the study begins.
Is there any evidence suggesting that SM-020 gel 1.0% is likely to be safe for humans?
Research shows that the safety of SM-020 gel 1.0% is being carefully monitored by tracking any unexpected medical problems and skin issues at the application site. Researchers are vigilant for any negative effects that might occur with gel use.
Since this trial is in the second phase of testing, some earlier data on safety exists, but more information is needed to confirm how well people tolerate the treatment. Generally, treatments in this phase have shown enough promise to continue, but researchers are still learning about all possible side effects. So far, the available data contains no detailed reports of serious problems.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for dermatosis papulosa nigra, which typically involve surgical or laser removal, SM-020 gel offers a non-invasive alternative. This gel is unique because it is applied topically, allowing for targeted treatment without the need for procedures that can be uncomfortable or costly. Researchers are excited because this approach could provide a more accessible and less intimidating option for patients, potentially reducing side effects associated with more invasive treatments.
What evidence suggests that SM-020 gel might be an effective treatment for Dermatosis Papulosa Nigra?
Research shows that SM-020 gel 1.0% is under development to treat dermatosis papulosa nigra (DPN), a skin condition causing small, dark bumps. While direct proof of its effectiveness for DPN is not yet available, this trial examines its potential benefits on these skin bumps. Participants will apply the gel twice daily for four weeks, and the study will assess changes in bump size. Early signs suggest it might help make these bumps less noticeable. Further research will determine its effectiveness.12456
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply SM-020 gel 1.0% twice daily for 4 consecutive weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SM-020 gel 1.0%
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
DermBiont, Inc.
Lead Sponsor
Citations
A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% ...
An open-label trial to explore the safety and efficacy of SM-020 gel 1.0% in subjects with Dermatosis Papulosa Nigra (DPN). Approximately 10 subjects will ...
SM-020 Gel for Dermatosis Papulosa Nigra
What data supports the effectiveness of the drug SM-020 gel 1.0% for treating dermatosis papulosa nigra? The research does not provide direct evidence for SM- ...
3.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/sm-020-dermbiont-dermatosis-likelihood-of-approval/SM-020 by DermBiont for Dermatosis: Likelihood of Approval
SM-020 is under development for the treatment of dermatosis papulosa nigra, non-melanoma skin cancers including basal cell carcinoma, squamous cell carcinoma ...
SM-020 - Drug Targets, Indications, Patents
Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor ...
Dermatosis Papulosa Nigra
Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra ... Treatment Outcomes for Dermatosis Papulosa Nigra ...
SM-020 Trials
NCT06099080: A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra (DPN). Active, not recruiting. 2.
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