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LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC

NCT04759664 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2023-10-06

No results posted yet for this study

Summary

The study evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions

Conditions

  • EGFRI Induced Acneiform Lesions

Interventions

DRUG

LUT014 Gel (Dose 1)

Topical gel

DRUG

LUT014 Gel (Dose 2)

Topical gel

DRUG

Placebo

LUT014 matching placebo topical gel

Sponsors & Collaborators

  • Lutris Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2024-03-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs

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 NCT04759664 on ClinicalTrials.gov