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Keratosis, Actinic

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Retinol

0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand

PEP005 gel

Arthur P Bertolino, MD

The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.

Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.

A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand

A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand

Omnicare Clinical Research

Peplin

Subjects will be exposed to investigational product for 2 consecutive days.

Subjects will be exposed to investigational product for 3 consecutive days.

PEP005 Gel

Jonathan Dosik, MD

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.

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.

LEO Pharma

Rikke L Fischer/International Clinical Trial Manager

Symptoms and General Pathology

Facies

PEP005 gel, 0.015% applied once daily for three consecutive days

Vehicle gel applied once daily for three consecutive days

Vehicle gel

Eugene Bauer, MD

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

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)

Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.

Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area

For the safety population, the total sample size was 132 patients who received PEP005 Gel (2 patients never received study medication and one patient actually received vehicle gel) and 135 patients who received vehicle gel.

PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days

PEP005 (Ingenol Mebutate) Gel, 0.015%

Vehicle gel once daily for 3 consecutive days

Vehicle

Total

Age, Categorical

Sex: Female, Male

United States

Australia

Region of Enrollment

Dr. Torsten Skov

PEP005 (Ingenol Mebutate) Gel

Vehicle Gel once daily for 3 consecutive days

Vehicle Gel

Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.

Patients With Partial Clearance of Actinic Keratosis (AK)

Overall Study

PEP005 gel, 0.05% administered once daily for 2 consecutive days

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand	NCT00544297	Actinic Keratos...	PEP005 gel	18 Years -	Peplin
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects	NCT01302925	Healthy Actinic Keratos...	PEP005 Gel PEP005 Gel	18 Years -	Peplin
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)	NCT00916006	Actinic Keratos...	PEP005 Gel Vehicle gel	18 Years -	Peplin
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)	NCT00917306	Actinic Keratos...	PEP005 Gel	18 Years -	Peplin
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects	NCT01302925	Healthy Actinic Keratos...	PEP005 Gel PEP005 Gel	18 Years -	Peplin
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)	NCT00916006	Actinic Keratos...	PEP005 Gel Vehicle gel	18 Years -	Peplin
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)	NCT00917306	Actinic Keratos...	PEP005 Gel	18 Years -	Peplin

Spots Global Cancer Trial Database for pep005 gel

Every month we try and update this database with for pep005 gel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pep005 gel

Every month we try and update this database with for pep005 gel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pep005 gel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.