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A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
NCT02654769 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.
Conditions Studied
Interventions
- DRUG Vehicle Foam
- DRUG Ingenol Mebutate (Picato®)
- DRUG Generic Ingenol Mebutate
Study Locations (20)
Florida
- The Center for Clinical and Cosmetic Research — Aventura
- Savin Medical Group Research Center — Miami Lakes
- Tory P. Sullivan, M.D., P.A. — North Miami Beach
- Moore Clinical Research, Inc. — Tampa
Indiana
- Shideler Clinical Research Center — Carmel
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis
- The Indiana Clinical Trials Center — Plainfield
California
- Center for Dermatology Clinical Research, Inc — Fremont
- SD Sports Medicine & Family Health Center — San Diego
Illinois
- Altman Dermatology Associates — Arlington Heights
- Christie Clinic, LLC — Champaign
North Carolina
- Dermatology Consulting Services — High Point
- PMG Research of Winston-Salem, LLC — Winston-Salem
Idaho
- Northwest Clinical Trials, Inc. — Boise
Nevada
- Bettencourt Skin Center — Henderson
New York
- Union Square Dermatology — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02654769
The ClinicalTrials.gov registry entry for NCT02654769 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 3 interventions — of which Vehicle Foam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02654769 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Indiana, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02654769 about?
NCT02654769 is a clinical study titled "A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis". The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extrem...
What is the current status of trial NCT02654769?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2015-02. Estimated completion is 2015-09.
What conditions does trial NCT02654769 study?
This clinical trial studies the following conditions: Actinic Keratosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02654769?
The interventions under investigation include: Vehicle Foam (DRUG), Ingenol Mebutate (Picato®) (DRUG), Generic Ingenol Mebutate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02654769?
This trial is sponsored by Actavis, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02654769 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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