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

NCT06099080 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CT-216
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatosis Papulosa Nigra

Outcome Measures

Primary Outcomes (2)

• 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

  Through week 16

• 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.

  Through week 16

Secondary Outcomes (14)

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

  Through week 16

• Time to DPNTLs achieving a DPNLA of 0

  Through week 16

• Percentage of subjects achieving clearance of all DPNTLs

  Through week 16

• Percentage of subjects achieving clearance of at least 60% of all DPNTLs

  Through week 16

• Percentage of all DPNTLs per subject achieving a DPNLA of 0

  Through week 16

Study Arms (1)

SM-020 gel 1.0%

EXPERIMENTAL

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.

Drug: SM-020 gel 1.0%

Interventions

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.

SM-020 gel 1.0%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DermBiont, Inc.: lead

Study Sites (1)

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

MeSH Terms

Conditions

Dermatosis Papulosa Nigra

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: November 7, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1)