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

Phase 1

Completed

• Conditions: Actinic Keratosis; Healthy
• Interventions: Drug: PEP005 Gel

• Registration Number: NCT01302925
• Lead Sponsor: Peplin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-24
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2015-09-11
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP005 Gel 0.05%/2 days	PEP005 Gel	Subjects will be exposed to investigational product for 2 consecutive days.
PEP005 Gel 0.015%/3 days	PEP005 Gel	Subjects will be exposed to investigational product for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
Local Skin Responses	Up to 8 days

Trial Locations

Locations (1)

TKL Research; 🇺🇸 Paramus, New Jersey, United States