To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
NCT02459795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 469
Last updated 2021-11-02
Summary
The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an FDA approved drug in the treatment of actinic keratosis.
Conditions
- Actinic Keratosis
Interventions
- DRUG
-
Ingenol Mebutate (Perrigo)
- DRUG
-
Ingenol Mebutate (Reference)
- DRUG
-
Placebo gel
Sponsors & Collaborators
-
Padagis LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
More Related Trials
-
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
NCT01998984 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT02361216 ·Status: COMPLETED ·Phase: PHASE3
-
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology
NCT01387711 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
NCT02406014 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm
NCT01803477 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
NCT01820260 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
NCT01836367 ·Status: COMPLETED ·Phase: PHASE1
-
Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis
NCT02354391 ·Status: UNKNOWN ·Phase: PHASE2
-
Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
NCT02716714 ·Status: COMPLETED ·Phase: PHASE4
-
TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
NCT04202445 ·Status: COMPLETED
-
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris
NCT02515305 ·Status: COMPLETED ·Phase: PHASE3
-
A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities
NCT01787383 ·Status: COMPLETED ·Phase: PHASE3
-
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
NCT02594436 ·Status: COMPLETED
-
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
NCT01600014 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
NCT00742391 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
NCT00917306 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis
NCT00852137 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Actinic Keratoses (AK) on the Face
NCT02411851 ·Status: COMPLETED ·Phase: PHASE1
-
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)
NCT00915551 ·Status: COMPLETED ·Phase: PHASE3
-
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects
NCT01302925 ·Status: COMPLETED ·Phase: PHASE1
-
Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions
NCT01735942 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
NCT00942604 ·Status: COMPLETED ·Phase: PHASE3
-
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
NCT03200912 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
NCT02525549 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
NCT00850681 ·Status: COMPLETED ·Phase: PHASE1