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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

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ClinicalTrials.gov Identifier: NCT00742391
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : March 21, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Peplin

Brief Summary:
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: PEP005 (ingenol mebutate) Gel Drug: Vehicle gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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-I)
Study Start Date : September 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
PEP005 (ingenol mebutate) Gel
Drug: PEP005 (ingenol mebutate) Gel
two day treatment

Placebo Comparator: 2
Vehicle gel
Drug: Vehicle gel
two day treatment




Primary Outcome Measures :
  1. Patients With Complete Clearance of Actinic Keratosis (AKs) [ Time Frame: 57 days ]
    Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.


Secondary Outcome Measures :
  1. Patients With Partial Clearance of Actinic Keratosis (AKs) [ Time Frame: baseline and 57 days ]
    Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742391


Locations
Show Show 20 study locations
Sponsors and Collaborators
Peplin

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00742391    
Other Study ID Numbers: PEP005-014
First Posted: August 27, 2008    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: March 6, 2015
Last Verified: March 2012
Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms