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

PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Actinic Keratosis
• Intervention / Treatment: Drug: PEP005 Gel; Drug: PEP005 Gel

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States
      • TKL Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be male or female and at least 18 years of age
• Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
• Ability to provide informed consent

Exclusion Criteria:

• Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks
• Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days
• Have any signs of skin irritation or damaged skin at or around the dominant index finger
• Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers
• Those who are currently participating in any other clinical trial
• Those known or suspected of not being able to comply with the requirements of the protocol
• Females who are pregnant or are breastfeeding

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEP005 Gel 0.05%/2 days; Subjects will be exposed to investigational product for 2 consecutive days.	Drug: PEP005 Gel; PEP005 Gel 0.05% for 2 consecutive days; Drug: PEP005 Gel; PEP005 Gel 0.015% for 3 consecutive days
EXPERIMENTAL: PEP005 Gel 0.015%/3 days; Subjects will be exposed to investigational product for 3 consecutive days.	Drug: PEP005 Gel; PEP005 Gel 0.05% for 2 consecutive days; Drug: PEP005 Gel; PEP005 Gel 0.015% for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local Skin Responses	Up to 8 days

Collaborators and Investigators

• Sponsor: Peplin
• Collaborators: LEO Pharma
• Investigators: Principal Investigator: Jonathan Dosik, MD, TKL Research

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (ESTIMATE): February 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: LP0041-01