Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis

NCT02716714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-04-18

Study results available
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Summary

This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp \& 0.05% on trunk and extremities in Korean patient with actinic keratosis.

Conditions

  • Actinic Keratosis

Interventions

DRUG

ingenol mebutate gel 0.015%

-Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days

DRUG

ingenol mebutate gel 0.05%

-Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY
  • Chonnam National University Hospital

    collaborator OTHER
  • Severance Hospital

    collaborator OTHER
  • Ajou University School of Medicine

    collaborator OTHER
  • Asan Medical Center

    collaborator OTHER
  • Samsung Medical Center

    collaborator OTHER
  • Seoul National University Bundang Hospital

    collaborator OTHER
  • Dong-A University Hospital

    collaborator OTHER
  • Korea University Anam Hospital

    collaborator OTHER
  • Seoul National University Hospital

    collaborator OTHER
  • Korea University

    lead OTHER

Principal Investigators

  • Ilhwan Kim, MD · Korea University Ansan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • South Korea

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 NCT02716714 on ClinicalTrials.gov