SM-020 Gel for Dermatosis Papulosa Nigra
Trial Summary
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.
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-020 gel 1.0% in treating dermatosis papulosa nigra, but it mentions the effectiveness of similar topical gels like ketoconazole and ingenol mebutate for other skin conditions, suggesting that topical gels can be effective for skin-related issues.12345
What makes SM-020 gel unique for treating dermatosis papulosa nigra?
The SM-020 gel 1.0% is unique because it is a topical treatment specifically formulated for dermatosis papulosa nigra, a condition with limited standard treatment options. Its gel form may offer better patient acceptance and adherence compared to creams, as seen with similar treatments like ketoconazole gel for other skin conditions.15678
What is the purpose of this trial?
This trial tests a special gel called SM-020 on people with small, dark skin bumps known as Dermatosis Papulosa Nigra (DPN). Participants will use the gel regularly for several weeks and be monitored over a few months to see if the gel is safe and effective.
Eligibility Criteria
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
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
Treatment Details
Interventions
- SM-020 gel 1.0%
Find a Clinic Near You
Who Is Running the Clinical Trial?
DermBiont, Inc.
Lead Sponsor