Completed PHASE3 INTERVENTIONAL 2-arm NCT00916006

A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)

Sponsor: Peplin

Conditions Actinic Keratosis

Interventions PEP005 Gel Vehicle gel

Updated 6 times since 2017 Last updated: Mar 13, 2015 Started: Jun 30, 2009 Primary completion: Sep 30, 2009 Completion: Sep 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Actinic Keratosis, this trial is completed. The trial is conducted by Peplin and has accumulated 6 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jun 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Peplin

Data source: Peplin

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alpharetta, United States , Buffalo Grove, United States , College Station, United States , Fort Gratiot, United States , Fridley, United States , Indianapolis, United States , Kogarah, Australia , Los Angeles, United States , Miami, United States , Nashville, United States and 10 more locations