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

NCT03200912 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2020-01-14

Study results available
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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.

Conditions

  • ACTINIC KERATOSIS

Interventions

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.

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Oleg Khatsenko, PhD · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-19
Primary Completion
2017-03-07
Completion
2017-03-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200912 on ClinicalTrials.gov