Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00917306
First received: June 8, 2009
Last updated: March 25, 2015
Last verified: March 2015

June 8, 2009
March 25, 2015
June 2009
September 2009   (final data collection date for primary outcome measure)
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
To evaluate the safety of PEP005 Gel when applied to patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00917306 on ClinicalTrials.gov Archive Site
Efficacy (complete and partial clearance of AK lesions) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
To evaluate the efficacy of PEP005 Gel when applied to patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Actinic Keratosis
Drug: PEP005 Gel
0.05% two day treatment
Other Name: PEP005
Experimental: PEP005 gel
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Intervention: Drug: PEP005 Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
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 patient must be of either:

    • Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
    • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria

  • Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
  • Treatment with immunomodulators, 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00917306
PEP005-020
No
Not Provided
Not Provided
Peplin
Peplin
TKL Research, Inc.
Study Director: Eugene Bauer, MD Chief Medical Officer
Peplin
March 2015

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