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

NCT05136144 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

DRUG

SM-020

Topical Akt Inhibitor SM-020 Gel

Sponsors & Collaborators

  • Zepeda Dermatologia

    collaborator UNKNOWN

  • DermBiont, Inc.

    lead INDUSTRY

Principal Investigators

  • David Zepeda, MD · Zepeda Dermatologia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2024-05-31
Completion
2024-07-31

Countries

  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136144 on ClinicalTrials.gov