To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

Phase 3

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Ingenol Mebutate (Reference); Drug: Placebo gel; Drug: Ingenol Mebutate (Perrigo)

• Registration Number: NCT02385318
• Lead Sponsor: Padagis LLC

Brief Summary

The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Disposition First Submitted: 2016-06-27
• Disposition First Submitted QC: 2016-06-27
• Disposition First Posted: 2016-06-29
• Results First Submitted: 2021-01-04
• Results First Submitted QC: 2021-01-04
• Results First Posted: 2021-01-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference product	Ingenol Mebutate (Reference)	Ingenol Mebutate
Placebo product	Placebo gel	Placebo gel
Test Product	Ingenol Mebutate (Perrigo)	Ingenol Mebutate

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Day 57