Dermatosis Papulosa Nigra
Conditions
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.
Interventions
DRUGSM-020 gel 1.0%
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.
Sponsors
DermBiont, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be able to comprehend and willing to sign an informed consent form (ICF) 2. 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 3. Must be a male or female \>18 years of age at the time of signing the informed consent form 4. Subject has Fitzpatrick Skin Type of 4, 5, or 6 5. Subject has a clinical diagnosis of Dermatosis Papulosa Nigra (DPN) 6. DPNTLs must: 1. 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). 2. 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) 3. Have a diameter that is ≥2mm but ≤5mm 4. Have a Physician's DPN Lesion Assessment Score (DPNLA) of \> 2 5. Be a discrete, well-defined, separate lesion 6. Not be covered with hair which, in the Investigator's opinion, would interfere with the study gel treatment or the study evaluations 7. Not be on the eyelids 8. Not be within 5mm of the orbital rim 9. Not be pedunculated 10. Not be inflamed, irritated, or excoriated 7. 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. 8. Must be willing and able to follow all study instructions and to attend all study visits. 9. Must be willing to have all partial or incompletely responding DPNTLs removed surgically by shave excision during the final visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of all DPNTLs that achieve clearance (DPNLA score of 0) | Through week 16 | 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 |
| Assessment of the severity of the Application Site Reactions and review of adverse events | Through week 16 | Signs and Symptoms of Application Site Reactions (ASRs) include pain, burning, stinging, pruritus, erythema, edema, exudation, erosion/ulceration, hyperpigmentation, and hypopigmentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Through week 16 | 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 |
| Percentage of all DPNTLs with a SSA of 0 | Through week 16 | 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 |
| Percent recurrence of all DPNTLs | Through week 16 | — |
| Proportion of all DPNTLs achieving a DPNLA of 0 or 1 | Through week 16 | The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion. |
| Comparison of the percentage of DPNTLs/subject achieving DPNLA 0 at week 16 to number of enrolled DPNTLs/subject | Through week 16 | — |
| Comparison of % clearance of DPNTLs at week 16 to onset, frequency, and severity of Application Site Reactions (ASRs) | Through week 16 | — |
| Comparison of % clearance of DPNTLs at week 16 to subject satisfaction assessment score | Through week 16 | — |
| Assess superiority of active over vehicle as measured by the subject satisfaction assessment score for their DPNTLs at week 16 | Through week 16 | — |
| Dermoscopic diagnostic accuracy of DPNTLs, as confirmed by histology at week 16 | Through week 16 | — |
| Comparison of DPNTLs achieving DPNLA 0 at week 16 to baseline greatest diameter | Through week 16 | — |
| Time to DPNTLs achieving a DPNLA of 0 | Through week 16 | The DPNLA is an Investigator assessment of DPN-variant of SK lesion severity based on presence of DPN and visibility of the DPN lesion. |
Countries
United States
Outcome results
None listed