Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Dermatitis, Phototoxic

Skin Diseases

Precancerous Conditions

PEP005 (ingenol mebutate) Gel

Jonothan S Dosik, MD

This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.

A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design

Peplin

Robert Whitfield

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design

Vehicle gel

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

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.

Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.

One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)

PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days

PEP005 (Ingenol Mebutate) Gel

Vehicle gel once daily for 2 consecutive days

Vehicle Gel

Total

Age, Continuous

Sex: Female, Male

United States

Australia

Region of Enrollment

Dr. Torsten Skov

Patients With Complete Clearance of Actinic Keratosis (AKs)

Patients With Partial Clearance of Actinic Keratosis (AKs)

Overall Study

Keratosis, Seborrheic

This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations

Jacqueline Morley, Clinical Research Team Leader

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)

Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area

Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers	NCT00850811	Actinic Keratos...	PEP005 (ingenol...	18 Years - 65 Years	Peplin
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers	NCT00850681	Actinic Keratos...	PEP005 (ingenol...	18 Years - 65 Years	Peplin
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations	NCT00742391	Actinic Keratos...	PEP005 (ingenol... Vehicle gel	18 Years -	Peplin
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis	NCT01214564	Seborrheic Kera...	PEP005 (ingenol...	18 Years -	Peplin
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations	NCT00942604	Actinic Keratos...	PEP005 (ingenol... Vehicle gel	18 Years -	Peplin
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations	NCT00942604	Actinic Keratos...	PEP005 (ingenol... Vehicle gel	18 Years -	Peplin

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