TrialSignal
Clinical trial intelligence report
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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 03, 2026
Report code
NCT02654769-Jul 03, 2026
NCT ID
NCT02654769
Status
COMPLETED
Phase
Phase 3
Sponsor
Actavis Inc.
Executive brief
Investment-Ready Snapshot
Actavis Inc. is conducting a Phase 3 clinical trial to establish the therapeutic equivalence of its generic ingenol mebutate gel (0.05%) against the branded Picato gel (0.05%) for the treatment of actinic keratosis (AK). The successful outcome of this trial could position Actavis favorably in the dermatological market, particularly as the patent for Picato is likely to expire, allowing for increased competition in the AK treatment space. The market for AK treatments is significant, with a growing prevalence of skin conditions due to aging populations and increased sun exposure. The trial's completion and positive results could enhance Actavis's portfolio and market share in dermatology, while also presenting potential cost-saving options for patients and healthcare systems.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT02654769
Indication
Actinic Keratosis
Modality
small molecule
Target
Ingenol Mebutate (mechanism of action involves inducing cell death in keratinocytes and promoting local immune response)
Intervention
Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.