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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00915551
First received: June 4, 2009
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Actinic Keratosis
 Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
Drug: Vehicle Gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
    Complete clearance of the treatment field


Secondary Outcome Measures:
  • Partial Clearance of Actinic Keratoses (AK) [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
    Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area


Enrollment: 278
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915551

  Show 21 Study Locations
Sponsors and Collaborators
Peplin
  More Information

Additional Information:
Food and Drug Authority  This link exits the ClinicalTrials.gov site
Therapeutic Goods Administration  This link exits the ClinicalTrials.gov site

No publications provided by Peplin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00915551     History of Changes
Other Study ID Numbers: PEP005-025
Study First Received: June 4, 2009
Results First Received: February 21, 2012
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods 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 23, 2013