NCT03200912

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (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, 0.015% 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.

Detailed description

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).

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: 2016-08-19
• Primary completion: 2017-03-07
• Completion: 2017-03-22
• First posted: 2017-06-27
• Last updated: 2020-01-14
• Results posted: 2020-01-14

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study