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Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions

NCT02124239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-02-24

No results posted yet for this study

Summary

This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups.

To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.

There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Ingenol mebutate

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Alicia D Bucko, MD · Academic Dermatology Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

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 NCT02124239 on ClinicalTrials.gov