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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Patients With Complete Clearance of Actinic Keratosis (AKs)

Outcome Description:

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.

Outcome Time Frame:

57 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-014

NCT ID:

NCT00742391

Start Date:

September 2008

Completion Date:

February 2009

Related Keywords:

  • Actinic Keratoses
  • Peplin
  • Actinic keratosis
  • PEP005
  • Keratosis
  • Keratosis, Actinic

Name

Location

Henry Ford Health SystemsDetroit, Michigan  48202
Oregon Health and Science UniversityPortland, Oregon  97201
Colorado Medical Research CenterDenver, Colorado  80210
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Park Avenue DermatologyOrange Park, Florida  32073
University Hospitals Case Medical CenterCleveland, Ohio  44106
Dermatology Associates of RochesterRochester, New York  14623
Oregon Medical ResearchCentre9495 SW Locust St., Suite G Portland, Oregon  97223
Rivergate Dermatology and Skin Care Center201 Bluebird Dr, Goodlettsville, Tennessee  
Gwinnett Clinical Research Centre2383 Pate St, Snellville, Georgia  30078-3250
Medaphase IncNewnan, Georgia  30263
Omni Dermatology ResearchMesa, Arizona  85206
Advanced Dermatology and Cosmetic ResearchKissimmee, Florida  34741
Advanced Dermatology & Cosmetic SurgeryOrmond Beach, Florida  32174
Dermatology Center of Indiana/Indiana Clinical Trials CenterPlainfield, Indiana  46168
Karen S. Harkaway, MD. LLCSouth Delran, New Jersey  08075
Dermatology EastGermantown, Tennessee  38138
J & S Studies, Inc.College Station, Texas  77845