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A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

NCT00700063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2015-04-14

Study results available
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Summary

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Conditions

  • Actinic Keratosis

Interventions

DRUG

PEP005 Topical Gel

0.005%, two days treatment

DRUG

PEP005 Topical Gel

0.01%, two days treatment

DRUG

PEP005 Topical Gel

0.015%, two days treatment

DRUG

Vehicle gel

two days treatment

DRUG

PEP005 Topical Gel

0.005%, three days treatment

DRUG

PEP005 Topical Gel

0.01%, three days treatment

DRUG

PEP005 Topical Gel

0.015%, three days treatment

DRUG

Vehicle gel

three days treatment

Sponsors & Collaborators

  • Peplin

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • 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 NCT00700063 on ClinicalTrials.gov