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
This study has been completed.
Sponsor:
Peplin
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00942604
First received: July 19, 2009
Last updated: March 21, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
| Condition | Intervention | Phase |
|---|---|---|
|
Actinic Keratoses |
Drug: PEP005 (ingenol mebutate) Gel Drug: Vehicle gel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib) |
Resource links provided by NLM:
Further study details as provided by Peplin:
Primary Outcome Measures:
- Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ] [ Designated as safety issue: No ]Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Secondary Outcome Measures:
- Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ] [ Designated as safety issue: No ]Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
| Enrollment: | 203 |
| Study Start Date: | July 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Drug: PEP005 (ingenol mebutate) Gel
two day treatment
|
|
Placebo Comparator: Vehicle gel
Vehicle gel once daily for 2 consecutive days
|
Drug: Vehicle gel
two day treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be male or female and at least 18 years of age.
- Female patients must be of:
- Non-childbearing potential;
- Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
- 4 to 8 AK lesions on non-head locations.
Exclusion Criteria:
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942604
Locations
| United States, Arizona | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arizona, United States, 71913 | |
| United States, California | |
| Skin Surgery Medical Group Inc. | |
| San Diego, California, United States, 92117 | |
| United States, Georgia | |
| Atlanta Dermatology, Vein & Research Center, LLC | |
| Alpharetta, Georgia, United States, 30022 | |
| United States, Illinois | |
| Altman Dermatology Associates | |
| Arlington Heights, Illinois, United States, 60005 | |
| Glazer Dermatology | |
| Buffalo Grove, Illinois, United States, 60089 | |
| United States, Indiana | |
| Deaconess Clinic Downtown | |
| Evansville, Indiana, United States, 47713 | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Nebraska | |
| Skin Specialists, PC | |
| Omaha, Nebraska, United States, 68144 | |
| United States, Nevada | |
| Karl G. Heine Dermatology | |
| Henderson, Nevada, United States, 89002 | |
| United States, Ohio | |
| Group Health Associates | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | |
| Houston, Texas, United States, 77056 | |
| Dermatology Clinical Research Center of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Dermatology Associates of Tyler | |
| Tyler, Texas, United States, 75703 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| The Education and Research Foundation | |
| Lynchburg, Virginia, United States, 24501 | |
| Virginia Clinical Research, Inc | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Peplin
More Information
Additional Information:
No publications provided by Peplin
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Peplin |
| ClinicalTrials.gov Identifier: | NCT00942604 History of Changes |
| Other Study ID Numbers: | PEP005-028 |
| Study First Received: | July 19, 2009 |
| Results First Received: | February 21, 2012 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Peplin:
|
Peplin Actinic keratosis PEP005 |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013