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A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

NCT01922050 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-03-06

Study results available
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Summary

Part 1:

To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Conditions

  • Actinic Keratosis

Interventions

DRUG

LEO 43204 Formulation 1

DRUG

LEO 43204 Formulation 2

DRUG

LEO 43204 Formulation 1 Dose X

DRUG

LEO 43204 Formulation 1 Dose Y

DRUG

LEO 43204 Formulation 2 Dose XX

DRUG

LEO 43204 Formulation 2 Dose YY

DRUG

Placebo Formulation 1

DRUG

Placebo Formulation 2

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Gary Goldenberg, MD · Mount Sinai School of Medicine, Dermatology Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States
  • Canada

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 NCT01922050 on ClinicalTrials.gov