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
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.
Indication: Actinic Keratosis
Modality: small molecule
Target: Ingenol Mebutate (mechanism of action involves inducing cell death in keratinocytes and promoting local immune response)
Sponsor: Actavis Inc.
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 02, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Ingenol Mebutate (mechanism of action involves inducing cell death in keratinocytes and promoting local immune response)
View original source fields
Condition raw: Actinic Keratosis
Condition normalized: Actinic Keratosis
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Ingenol Mebutate (mechanism of action involves inducing cell death in keratinocytes and promoting local immune response)
Target normalized: Ingenol Mebutate (mechanism of action involves inducing cell death in keratinocytes and promoting local immune response)