Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00915551
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : March 16, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Peplin

Brief Summary:
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 (Ingenol Mebutate) gel, 0.015% Drug: Vehicle Gel Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)
Study Start Date : June 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEP005 (Ingenol Mebutate) gel Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days

Placebo Comparator: Vehicle gel Drug: Vehicle Gel
once daily for 3 consecutive days




Primary Outcome Measures :
  1. Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ]
    Complete clearance of the treatment field


Secondary Outcome Measures :
  1. Partial Clearance of Actinic Keratoses (AK) [ Time Frame: baseline and 57 days ]
    Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female and at least 18 years of age
  • Female patients must be of either:

    • Non-childbearing potential, post-menopausal
    • Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria:

  • Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected 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): NCT00915551


Locations
Show Show 21 study locations
Sponsors and Collaborators
Peplin

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00915551    
Other Study ID Numbers: PEP005-025
First Posted: June 8, 2009    Key Record Dates
Results First Posted: March 16, 2012
Last Update Posted: March 6, 2015
Last Verified: November 2013
Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms