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

Primary Purpose

Dermatosis Papulosa Nigra

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SM-020 gel 1.0%
Sponsored by
DermBiont, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatosis Papulosa Nigra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: 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. Exclusion Criteria: 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: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SM-020 gel 1.0%

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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.
    Percentage of subjects achieving clearance of all DPNTLs
    Percentage of subjects achieving clearance of at least 60% of all DPNTLs
    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.
    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 Mild: Slightly raised DPN lesion Moderate: Obviously raised DPN lesion Severe: Prominent DPN lesion
    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 Mild: Slightly raised DPN lesion Moderate: Obviously raised DPN lesion Severe: Prominent DPN lesion
    Percent recurrence of all DPNTLs
    Comparison of DPNTLs achieving DPNLA 0 at week 16 to baseline greatest diameter
    Comparison of the percentage of DPNTLs/subject achieving DPNLA 0 at week 16 to number of enrolled DPNTLs/subject
    Comparison of % clearance of DPNTLs at week 16 to onset, frequency, and severity of Application Site Reactions (ASRs)
    Comparison of % clearance of DPNTLs at week 16 to subject satisfaction assessment score
    Assess superiority of active over vehicle as measured by the subject satisfaction assessment score for their DPNTLs at week 16
    Dermoscopic diagnostic accuracy of DPNTLs, as confirmed by histology at week 16

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    DermBiont, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099080
    Brief Title
    A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra (DPN)
    Official Title
    Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Dermatosis Papulosa Nigra
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 23, 2023 (Anticipated)
    Primary Completion Date
    March 21, 2024 (Anticipated)
    Study Completion Date
    May 24, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    DermBiont, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatosis Papulosa Nigra

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SM-020 gel 1.0%
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    SM-020 gel 1.0%
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of all DPNTLs that achieve clearance (DPNLA score of 0)
    Description
    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 Near Clear: a slightly visible DPN lesion; lesion may be macular Small: a visible DPN lesion with a diameter of less than 3 mm Large: a visible DPN lesion that is elevated with a diameter > 3mm
    Time Frame
    Through week 16
    Title
    Assessment of the severity of the Application Site Reactions and review of adverse events
    Description
    Signs and Symptoms of Application Site Reactions (ASRs) include pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation.
    Time Frame
    Through week 16
    Secondary Outcome Measure Information:
    Title
    Proportion of all DPNTLs achieving a DPNLA of 0 or 1
    Description
    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.
    Time Frame
    Through week 16
    Title
    Time to DPNTLs achieving a DPNLA of 0
    Description
    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.
    Time Frame
    Through week 16
    Title
    Percentage of subjects achieving clearance of all DPNTLs
    Time Frame
    Through week 16
    Title
    Percentage of subjects achieving clearance of at least 60% of all DPNTLs
    Time Frame
    Through week 16
    Title
    Percentage of all DPNTLs per subject achieving a DPNLA of 0
    Description
    The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion.
    Time Frame
    Through week 16
    Title
    Percentage of all DPNTLs with a SSA (Subject's Self-Assessment) of 0 or 1
    Description
    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 Mild: Slightly raised DPN lesion Moderate: Obviously raised DPN lesion Severe: Prominent DPN lesion
    Time Frame
    Through week 16
    Title
    Percentage of all DPNTLs with a SSA of 0
    Description
    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 Mild: Slightly raised DPN lesion Moderate: Obviously raised DPN lesion Severe: Prominent DPN lesion
    Time Frame
    Through week 16
    Title
    Percent recurrence of all DPNTLs
    Time Frame
    Through week 16
    Title
    Comparison of DPNTLs achieving DPNLA 0 at week 16 to baseline greatest diameter
    Time Frame
    Through week 16
    Title
    Comparison of the percentage of DPNTLs/subject achieving DPNLA 0 at week 16 to number of enrolled DPNTLs/subject
    Time Frame
    Through week 16
    Title
    Comparison of % clearance of DPNTLs at week 16 to onset, frequency, and severity of Application Site Reactions (ASRs)
    Time Frame
    Through week 16
    Title
    Comparison of % clearance of DPNTLs at week 16 to subject satisfaction assessment score
    Time Frame
    Through week 16
    Title
    Assess superiority of active over vehicle as measured by the subject satisfaction assessment score for their DPNTLs at week 16
    Time Frame
    Through week 16
    Title
    Dermoscopic diagnostic accuracy of DPNTLs, as confirmed by histology at week 16
    Time Frame
    Through week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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: 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. Exclusion Criteria: 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: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joanna Jay
    Phone
    510-607-8155
    Email
    joanna.j@dermbiont.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emma Taylor
    Phone
    510-607-8155
    Email
    emma@dermbiont.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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