10 Participants Needed

SM-020 Gel for Dermatosis Papulosa Nigra

JJ
ET
Overseen ByEmma Taylor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

DPNTLs must have a Physician's DPN Lesion Assessment Score (DPNLA) of > 2
My skin lesions are not close to the edge of my eye socket.
My skin lesions are between 2mm and 5mm in size.
See 17 more

Exclusion Criteria

I haven't used microdermabrasion or chemical peels in the last 14 days.
I haven't taken immunosuppressive drugs in the last 28 days.
I haven't taken anti-metabolites like methotrexate in the last 28 days.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply SM-020 gel 1.0% twice daily for 4 consecutive weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

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.
Participant Groups
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.

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Who Is Running the Clinical Trial?

DermBiont, Inc.

Lead Sponsor

Trials
14
Recruited
740+

References

Ketoconazole gel 2% in the treatment of moderate to severe seborrheic dermatitis. [2013]
Assessment of Efficacy and Irritation of Ingenol Mebutate Gel 0.015% Used With or Without Dimethicone Lotion for Treatment of Actinic Keratosis on the Face. [2018]
The role of ingenol mebutate in the treatment of actinic keratoses. [2021]
Disseminated superficial actinic porokeratosis treated with ingenol mebutate gel 0.05. [2017]
[Treatment of seborrhoeic eczema with ketoconazole in comparison with an active agent-free cream]. [2013]
Use of minipig skin biopsy model as an innovative tool to design topical formulation to achieve desired pharmacokinetics in humans. [2015]
Mometasone furoate hydrogel for scalp use: in vitro and in vivo evaluation. [2017]
Comparative study of ketoconazole 2% foaming gel and betamethasone dipropionate 0.05% lotion in the treatment of seborrhoeic dermatitis in adults. [2018]
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