NCT02654769

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Ingenol Mebutate (Picato®)	Brand product
DRUG	Generic Ingenol Mebutate	Generic formulated to have the same therapeutic effect of the brand
DRUG	Vehicle Foam	It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2016-01-13
• Last updated: 2020-05-12
• Results posted: 2020-05-12

Locations

22 sites across 1 country: United States