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Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

NCT01998984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2025-03-10

Study results available
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Summary

This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Conditions

  • Actinic Keratosis

Interventions

DRUG

ingenol mebutate

OTHER

Placebo

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Daniel M Siegel, MD, MS · Lond Island Skin Cancer and Dermatologic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

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 NCT01998984 on ClinicalTrials.gov