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: November 22, 2013
Last verified: November 2013

June 4, 2009
November 22, 2013
June 2009
September 2009   (final data collection date for primary outcome measure)
Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
Complete clearance of the treatment field
To evaluate the efficacy of PEP005 Gel, 0.015% when applied in patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00915551 on ClinicalTrials.gov Archive Site
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
To evaluate the safety of PEP005 Gel, 0.015% when applied in patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Actinic Keratosis
  • Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
    once daily for 3 consecutive days
  • Drug: Vehicle Gel
    once daily for 3 consecutive days
  • Experimental: PEP005 (Ingenol Mebutate) gel
    Intervention: Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
  • Placebo Comparator: Vehicle gel
    Intervention: Drug: Vehicle Gel
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00915551
PEP005-025
No
Peplin
Peplin
Not Provided
Not Provided
Peplin
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP