Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis

NCT05136144 | Unknown Phase 2

• 1 other identifier: DBI-SM-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.

Conditions

Seborrheic Keratosis

Outcome Measures

Primary Outcomes (3)

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Measured by the proportion of all SKTLs (Seborrheic Keratosis Target Lesion) that achieve clearance (PLA score of 0) at final study visit

  Through 20 weeks

• Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day QD treatment with SM-020 gel 1.0%

  Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)

  Through 20 weeks

• Superiority of 28-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 0.1%

  Measured by the proportion of all SKTLs that achieve clearance (PLA score of 0)

  Through 20 weeks

Secondary Outcomes (8)

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Through 20 weeks

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Through 20 weeks

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Through 20 weeks

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Through 20 weeks

• Superiority of 56-day BID treatment with SM-020 gel 1.0% over 28-day BID treatment with SM-020 gel 1.0%

  Through 20 weeks

Study Arms (1)

SM-020

EXPERIMENTAL

Topical Akt Inhibitor SM-020 Gel

Drug: SM-020

Interventions

SM-020 DRUG

Topical Akt Inhibitor SM-020 Gel

SM-020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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).
• At least 18 years of age.
• Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 will be targeted for treatment. There will be a maximum of 5 PLA 2's per subject. An eligible SKTL must each:
• Have one or more of the following clinical features throughout the entirety of the lesion consistent with SKs: stuck-on, warty, waxy, scaly, milia-like cyst, tan to black
• For subjects randomized for assessment with clinical diagnosis and dermoscopy, SKs must also have one or more of the dermoscopy features throughout the entirety of the lesion: moth-eaten border, fingerprinting structures, network-like pattern, network pattern, crypts (comedo-like openings), milia cysts, pinpoint vessels, hairpin vessels, fat fingers, sharp demarcation, blue-white pigmentation, more than one color, cerebriform structure, irregular, polymorphic pattern, fissures, white artefacts, irregular vessels (Simionescu et al., 2012).
• Have a Physician's Lesion Assessment (PLA) of 2 (a thickness that is ≤1mm) or 3 (a thickness that is \>1mm)
• Have a greatest diameter that is ≥5mm and ≤15mm
• 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 pedunculated
• Not be on the eyelid
• Not be within 5mm of the orbital rim
• Must be free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of any SKTL 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.
• As applicable, technical ability and willingness to apply Investigational Product (IP).

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 for the duration of the study.
• SK lesions that are clinically atypical and/or rapidly growing in size.
• Presence of multiple eruptive 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:
• Retinoids; 180 days
• Glucocorticosteroids; 28 days
• Anti-metabolites (e.g., methotrexate); 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 on, or in a proximity to any SKTL 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-fluorouracil, 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 SKTL that, in the Investigator's opinion, could interfere with the investigational product study treatment applications or the study assessments:

Sponsors & Collaborators

• DermBiont, Inc.: lead
• Zepeda Dermatologia: collaborator

Study Sites (1)

Zepeda Dermatologia

Santa Tecla, La Libertad Department, El Salvador

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Zepeda, MD

  Zepeda Dermatologia

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Adaptive design

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 29, 2021
• Study Start: October 19, 2021
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)