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PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

NCT01302925 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-14

No results posted yet for this study

Summary

The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.

Conditions

  • Healthy
  • Actinic Keratosis

Interventions

DRUG

PEP005 Gel

PEP005 Gel 0.05% for 2 consecutive days

DRUG

PEP005 Gel

PEP005 Gel 0.015% for 3 consecutive days

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY

  • Peplin

    lead INDUSTRY

Principal Investigators

  • Jonathan Dosik, MD · TKL Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT01302925 on ClinicalTrials.gov