At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 265 enrolled
Drug / intervention
PEP005 Topical Gel +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
In Brief
A Phase 2 clinical trial evaluating PEP005 Topical Gel and Vehicle gel for Actinic Keratosis. Completed, enrolled 265 participants across 28 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesAustralia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJun 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.0 years ago
Interventions
PEP005 Topical Geldrug
0.005%, two days treatment
PEP005 Topical Geldrug
0.01%, two days treatment
PEP005 Topical Geldrug
0.015%, two days treatment
Vehicle geldrug
two days treatment
PEP005 Topical Geldrug
0.005%, three days treatment
PEP005 Topical Geldrug
0.01%, three days treatment
PEP005 Topical Geldrug
0.015%, three days treatment
Vehicle geldrug
three days treatment