Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Generic ingenol mebutate gel, 0.05% \[Test\]

Ingenol Mebutate (Picato®)

Generic formulated to have the same therapeutic effect of the brand

Generic Ingenol Mebutate

It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Vehicle Foam

Oleg Khatsenko, Ph.D

The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.

Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.

A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis

Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities

Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.

Actavis Inc.

Generic ingenol mebutate gel, 0.05% \[Test\]

Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand

Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Ingenol Mebutate (Picato®): Brand product

Active Comparator Picato®

Vehicle gel of the test product

Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Typical features: Pale white skin, blue/hazel eyes, blond/red hair. Tanning ability: Always burns, does not tan.

Fitzpatrick Skin Type I

Typical features: fair skin, blue eyes. Tanning ability: burns easily, tans poorly.

Fitzpatrick Skin Type II

Typical features: darker white skin. Tanning ability: tans after initial burn.

Fitzpatrick Skin Type III

Typical features: light brown skin. Tanning ability: burns minimally, tans easily.

Fitzpatrick Skin Type IV

Typical features: brown skin. Tanning ability: rarely burns, tans darkly easily.

Fitzpatrick Skin Type V

Subjects in Modified Intent-to-Treat Population

Senior Director, Clinical R&D

Primary Efficacy Outcome Measure

The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.

Overall Study

Symptoms and General Pathology

Facies

Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Generic ingenol mebutate gel, 0.15% \[Test\]

Oleg Khatsenko, PhD

The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.

Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).

An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

A Multicenter Randomized Doubleblind Vehicle-controlled Parallel Comparison Study to Determine Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.015% and Picato® Gel 0.015% in Subjects With Actinic Keratosis on the Face or Scalp

Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area

Generic ingenol mebutate gel, 0.015% \[Test\]

Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand

Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]

Ingenol Mebutate (Picato®): Brand product

Picato (Ingenol Mebutate)

Vehicle gel of the test product

Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Vehicle Gel

Senior Director, CE Studies

AK Complete Clearance Rate at Day 57 (PP population)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis	NCT02654769	Actinic Keratos...	Ingenol Mebutat... Generic Ingenol... Vehicle Foam	18 Years - 95 Years	Actavis Inc.
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis	NCT03200912	ACTINIC KERATOS...	Ingenol Mebutat... Generic Ingenol... Vehicle Foam	18 Years - 95 Years	Actavis Inc.

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