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PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities

NCT01325688 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-02-26

No results posted yet for this study

Summary

This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.

Conditions

  • Superficial Basal Cell Carcinoma

Interventions

DRUG

PEP005 (ingenol mebutate) Gel, 0.05%

PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days

DEVICE

Aluminium disk

DEVICE

OpSite(TM) disk

Sponsors & Collaborators

  • Peplin

    lead INDUSTRY

Principal Investigators

  • Jacqueline Morley · Peplin Operations

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Australia

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 NCT01325688 on ClinicalTrials.gov