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A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

NCT01541553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2025-03-10

Study results available
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Summary

The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Conditions

  • Actinic Keratosis

Interventions

PROCEDURE

Cryotherapy

Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area

DRUG

Vehicle

Field treatment with vehicle gel once daily for 3 consecutive days.

DRUG

Ingenol metabute

Field treatment with vehicle gel once daily for 3 consecutive days.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Brian Berman, MD, Ph.D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-07-31
Completion
2013-07-31

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 NCT01541553 on ClinicalTrials.gov