What side effects are associated with this type of intervention?

Common side effects of topical treatments for Dermatosis Papulosa Nigra (DPN) include local skin reactions such as redness, itching, burning, and irritation. There may also be a risk of skin discoloration or hyperpigmentation, particularly in individuals with darker skin tones. Prolonged use of some topical agents can lead to skin thinning or atrophy. It is important to monitor for these potential side effects and discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments targeting Dermatosis Papulosa Nigra (DPN). However, topical treatments are commonly used for various dermatological conditions. For instance, fluocinonide 0.05% cream has been evaluated for recalcitrant dermatoses, showing significant improvement in patients. While not specifically approved for DPN, such topical corticosteroids and other investigational topical agents like SM-020 gel 1.0% are being studied for their efficacy in treating skin lesions.

What other types of research exist?

Promising novel alternatives to SM-020 gel 1.0% for Dermatosis Papulosa Nigra (DPN) patients in 2024 could include topical tacrolimus, imiquimod, and podofilox, which have been effective in other dermatological conditions. Additionally, treatments involving microneedling and polynucleotides may offer potential benefits and should be explored further with a healthcare provider.

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SM-020 Gel for Dermatosis Papulosa Nigra

Q: What is the mechanism of action of this treatment?

Common treatments for Dermatosis Papulosa Nigra (DPN) often involve topical agents that work through mechanisms such as keratolysis, which helps in the shedding of the outer skin layer, anti-inflammatory effects to reduce skin irritation, and inhibition of melanin production to lighten the lesions. For instance, the investigational SM-020 gel 1.0% being studied aims to target DPN lesions by potentially combining these mechanisms to effectively reduce the size and appearance of the lesions. Understanding these mechanisms is important for patients as it provides insight into how the treatment works and what outcomes they can anticipate.

Phase 2

Waitlist Available

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

Must not have

Use of immunosuppressive therapy within 28 days prior to the Baseline visit and while on study

Use of anti-metabolites (e.g., methotrexate) within 28 days prior to the Baseline visit and while on study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through week 16

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken immunosuppressive drugs in the last 28 days.

Select...

I haven't taken anti-metabolites like methotrexate in the last 28 days.

Select...

I haven't used specific skin treatments in the last 60 days.

Select...

My skin lesions are unusual or growing quickly.

Select...

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

Select...

I have multiple sudden skin growths.

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I have cancer that is spreading in my body.

Select...

I haven't used retinoids in the last 6 months.

Select...

I haven't had chemotherapy in the last 6 months.

Select...

I haven't used retinoids in the last 28 days and won't use them during the study.

Select...

I have a skin condition near my tumor that could turn into cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Percentage of all DPNTLs per subject achieving a DPNLA of 0

Percentage of all DPNTLs with a SSA (Subject's Self-Assessment) of 0 or 1

Percentage of all DPNTLs with a SSA of 0

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dermatosis Papulosa Nigra (DPN) often involve topical agents that work through mechanisms such as keratolysis, which helps in the shedding of the outer skin layer, anti-inflammatory effects to reduce skin irritation, and inhibition of melanin production to lighten the lesions. For instance, the investigational SM-020 gel 1.0% being studied aims to target DPN lesions by potentially combining these mechanisms to effectively reduce the size and appearance of the lesions. Understanding these mechanisms is important for patients as it provides insight into how the treatment works and what outcomes they can anticipate.

Pulsed dye laser alone versus its combination with topical ivermectin 1% in treatment of Rosacea: a randomized comparative study.Prospective pilot study on combined use of pulsed dye laser and 1% topical rapamycin for treatment of nonfacial cutaneous capillary malformation.Systematic review of treatment modalities for gingival depigmentation: a random-effects poisson regression analysis.