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Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

NCT02361216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 729

Last updated 2025-03-10

Study results available
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Summary

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Ingenol Mebutate

OTHER

Vehicle

Vehicle gel

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • C. William Hanke, MD · Laser & Skin Surgery Center of Indiana,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-03-31
Completion
2017-03-31

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 NCT02361216 on ClinicalTrials.gov