Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02654769 · ClinicalTrials.gov registry record · Phase 3
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
A Phase 3 study of Actinic Keratosis, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 441
- Enrollment target
- 20
- Study locations
NCT02654769: Completed Phase 3 study of Actinic Keratosis, sponsored by Actavis.
NCT02654769 is a Phase 3 study of Actinic Keratosis that has completed, run by Actavis. The registered enrollment target is 441 participants, above the 161-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02654769, a Phase 3 study of Actinic Keratosis, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 441 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.
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 |
What the finished NCT02654769 record still lists
NCT02654769 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, above the 161-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (174% higher).
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.
NCT02654769 names 20 study sites across 12 states, led by Florida, Indiana, California.
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.
What interventions are being tested in trial NCT02654769?
The interventions under investigation include: Vehicle Foam (DRUG), Ingenol Mebutate (Picato®) (DRUG), Generic Ingenol Mebutate (DRUG).
Who is sponsoring clinical trial NCT02654769?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Actinic Keratosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02654769's enrollment target sits among peer trials
441 2nd of 16 the highest of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
ACTIVE NOT RECRUITING · Phase 3
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
ACTIVE NOT RECRUITING · Phase 3
-
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
COMPLETED · Phase 3
-
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
COMPLETED · Phase 3
-
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
COMPLETED · Phase 3
-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02679144 · 441 participants · Phase 2
Neuroblastoma Maintenance Therapy Trial
- NCT03704766 · 442 participants · NA
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
- NCT04657068 · 442 participants · Phase 1
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
- NCT05410145 · 442 participants · Phase 1
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia