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Dermatosis Papulosa NigraPhase 2NCT06099080

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

A Phase 2 study testing SM-020 gel 1.0% in people with Dermatosis Papulosa Nigra, run by DermBiont, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 be enrolled with DPNs to apply SM-020 gel 1.0%. Each subject must have a minimum of 5 eligible DPNTLs with a diameter ≥2mm but ≤5mm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatosis Papulosa Nigra
What is being tested?
SM-020 gel 1.0%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
7 Nov 2023to 25 Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be able to comprehend and willing to sign an informed consent form (ICF)
  • Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information
  • Must be a male or female >18 years of age at the time of signing the informed consent form
  • Subject has Fitzpatrick Skin Type of 4, 5, or 6
  • Subject has a clinical diagnosis of Dermatosis Papulosa Nigra (DPN)
  • DPNTLs must:
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  • Have a minimum of 5 eligible facial DPNTLs. A maximum 10 DPNTLs will be targeted for treatment. An eligible DPNTL 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 (Duffill, 2008).
  • For subjects randomized for eligibility assessment with dermoscopy, DPNTLs must also have one or more of the following dermoscopy features throughout the entirety of the lesion: milia-like cysts, comedo-like openings, fissures/ridges, cerebriform surface (fat fingers)
  • Have a diameter that is ≥2mm but ≤5mm
  • Have a Physician's DPN Lesion Assessment Score (DPNLA) of > 2
  • Be a discrete, well-defined, separate lesion
  • Not be covered with hair which, in the Investigator's opinion, would interfere with the study gel treatment or the study evaluations
  • Not be on the eyelids
  • Not be within 5mm of the orbital rim
  • Not be pedunculated
  • Not be inflamed, irritated, or excoriated
  • Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any DPNTL or which exposes the subject to an unacceptable risk by study participation.
  • Must be willing and able to follow all study instructions and to attend all study visits.
  • Must be willing to have all partial or incompletely responding DPNTLs removed surgically by shave excision during the final visit.

Who cannot join

  • Exclusion Criteria Subjects meeting any of the following criterion will be ineligible and excluded from this study:
  • Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control (such as oral contraceptive pills (OCPs), Intrauterine devices (IUDs), birth control implants, vaginal rings, or injections) for the duration of the study.
  • DPN lesions that are clinically atypical and/or rapidly growing in size or number.
  • Presence of multiple eruptive DPN or SK lesions (sign of Leser-Trelat)
  • Current systemic malignancy.
  • Any use of the following systemic therapies within the specified period, or unwilling to meet the following washouts, prior to the Baseline visit and while on study:
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  • Retinoids; 180 days
  • Chemotherapy; 180 days
  • Immunosuppressive therapy; 28 days
  • Biologics (e.g., interferon, interferon inducers, or immunomodulators); 28 days
  • Glucocorticosteroids; 28 days
  • Anti-metabolites (e.g., methotrexate); 28 days
  • Vismodegib; 180 days
  • Known photosensitizing medications or CYP3A inducers/inhibitors; 28 days
  • Any use of the following topical therapies within the specified period, or unwilling to meet the following washouts, prior to the Baseline visit and while on study, or in a proximity to any DPNTL, that in the Investigator's opinion could interfere with the investigational product study treatment applications or the study assessments:
  • Laser, light or other energy-based therapy [e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)]; 180 days
  • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate; 60 days
  • Retinoids; 28 days
  • Microdermabrasion or superficial chemical peels; 14 days
  • Glucocorticosteroids or antibiotics; 14 days
  • Occurrence or presence of any of the following within the specified period prior to the Baseline visit on or in the proximity of any DPNTL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:
  • Cutaneous malignancy; 180 days
  • Sunburn; currently
  • A pre-malignancy (e.g., actinic keratosis); currently
  • Body art (e.g., tattoos, piercing, etc.); currently
  • History of sensitivity to any of the ingredients in the investigational product.
  • Any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or other condition(s) (e.g., sunburn, excessive hair, open wounds, lupus, photosensitive disorders etc.) that, in the opinion of the Investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
  • Participation in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to the Screening visit.
  • History of hypertrophic scarring or keloid formation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California, 90036

Other trials in United States

About this study

Official title: Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra

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 be enrolled with DPNs to apply SM-020 gel 1.0%. Each subject must have a minimum of 5 eligible DPNTLs with a diameter ≥2mm but ≤5mm. A maximum of 10 DPNs per subject will be targeted for 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. A total of 5-10 eligible Dermatosis Papulosa Nigra Target Lesions (DPNTLs) will be treated per subject.

Being tested
SM-020 gel 1.0%
Medical subject headings
Dermatosis Papulosa Nigra

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SM-020 gel 1.0%Drug

    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.

Study groups in NCT06099080
Study groupRoleWhat they receive
SM-020 gel 1.0%ExperimentalSubjects 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.
Receives: Drug: SM-020 gel 1.0%

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.

    0 Clear: no visible DPN lesion

    1. Near Clear: a slightly visible DPN lesion; lesion may be macular
    2. Small: a visible DPN lesion with a diameter of less than 3 mm
    3. Large: a visible DPN lesion that is elevated with a diameter > 3mm

    Measured: Through week 16

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

    Signs and Symptoms of Application Site Reactions (ASRs) include pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation.

    Measured: Through week 16

Secondary outcomes (14)

  1. Proportion of all DPNTLs achieving a DPNLA of 0 or 1

    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.

    Measured: Through week 16

  2. Time to DPNTLs achieving a DPNLA of 0

    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.

    Measured: Through week 16

  3. Percentage of subjects achieving clearance of all DPNTLs

    Measured: Through week 16

  4. Percentage of subjects achieving clearance of at least 60% of all DPNTLs

    Measured: Through week 16

  5. Percentage of all DPNTLs per subject achieving a DPNLA of 0

    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.

    Measured: Through week 16

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

    The SSA is a subject's self-reported assessment of DPN lesion severity based on presence and visible elevation of a DPN lesion. The SSA will be determined by all subjects for each DPNTL at all study visits from Visit 1/Screening to Visit 9/Last Visit

    0 No visible DPN lesion

    1. Mild: Slightly raised DPN lesion
    2. Moderate: Obviously raised DPN lesion
    3. Severe: Prominent DPN lesion

    Measured: Through week 16

  7. Percentage of all DPNTLs with a SSA of 0

    The SSA is a subject's self-reported assessment of DPN lesion severity based on presence and visible elevation of a DPN lesion. The SSA will be determined by all subjects for each DPNTL at all study visits from Visit 1/Screening to Visit 9/Last Visit

    0 No visible DPN lesion

    1. Mild: Slightly raised DPN lesion
    2. Moderate: Obviously raised DPN lesion
    3. Severe: Prominent DPN lesion

    Measured: Through week 16

  8. Percent recurrence of all DPNTLs

    Measured: Through week 16

  9. Comparison of DPNTLs achieving DPNLA 0 at week 16 to baseline greatest diameter

    Measured: Through week 16

  10. Comparison of the percentage of DPNTLs/subject achieving DPNLA 0 at week 16 to number of enrolled DPNTLs/subject

    Measured: Through week 16

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

    Measured: Through week 16

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

    Measured: Through week 16

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

    Measured: Through week 16

  14. Dermoscopic diagnostic accuracy of DPNTLs, as confirmed by histology at week 16

    Measured: Through week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start7 Nov 2023
  3. Primary completion25 Jul 2024 (estimated)
  4. Study completion25 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099080
Sponsor's protocol ID
CT-216
Status last verified
Apr 2024
First submitted
19 Oct 2023
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SM-020 gel 1.0% in people with Dermatosis Papulosa Nigra, run by DermBiont, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of all DPNTLs that achieve clearance (DPNLA score of 0) (time frame: Through week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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