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 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2015-03-06
Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Conditions
- Actinic Keratoses
Interventions
- DRUG
-
PEP005 (ingenol mebutate) Gel
two day treatment
- DRUG
-
Vehicle gel
two day treatment
Sponsors & Collaborators
-
Peplin
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- United States
Study Locations
More Related Trials
-
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063 ·Status: COMPLETED ·Phase: PHASE2
-
Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
NCT01836367 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
NCT01214564 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
NCT00427050 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
NCT00375739 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
NCT00544297 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
NCT00850681 ·Status: COMPLETED ·Phase: PHASE1
-
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
NCT00989313 ·Status: COMPLETED
-
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
NCT00850811 ·Status: COMPLETED ·Phase: PHASE1
-
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
NCT01600014 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT02361216 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
NCT00107965 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel
NCT00239135 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
NCT00659893 ·Status: COMPLETED ·Phase: PHASE1
-
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology
NCT01387711 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks
NCT02090465 ·Status: COMPLETED
-
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
NCT01926496 ·Status: COMPLETED ·Phase: PHASE4
-
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
NCT01449513 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
NCT02242747 ·Status: COMPLETED ·Phase: NA
-
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
NCT01541553 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
NCT02124239 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
NCT02716714 ·Status: COMPLETED ·Phase: PHASE4
-
Treatment of Actinic Keratoses (AK) on the Face
NCT02411851 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
NCT00544258 ·Status: COMPLETED ·Phase: PHASE1