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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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)


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

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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Clearance of Actinic Keratoses (AK) Lesions

Outcome Description:

Complete clearance of the treatment field

Outcome Time Frame:

baseline and 57 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-025

NCT ID:

NCT00915551

Start Date:

June 2009

Completion Date:

September 2009

Related Keywords:

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

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
North Florida Dermatology Associates, PAJacksonville, Florida  32204
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Premier Clinical ResearchSpokane, Washington  99204
Progressive Clinical ResearchSan Antonio, Texas  78229
Burke Pharmaceutical ResearchHot Springs, Arizona  71913
Skin Specialists, PCOmaha, Nebraska  
Center for DermatologyFremont, California  94538
Laser Skin Surgery Center of IndianaCarmel, Indiana  46032
Deaconess Clinic, IncEvansville, Indiana  47713
The Indiana Clinical Trials Center, PCPlainfield, Indiana  46168
Karl G. Heine DermatologyHenderson, Nevada  89002
Dermatology Associates of Rochester, PCRochester, New York  14623
Dermatology, Laser Vein Specialists of the CarolinasCharlotte, North Carolina  28207
Oregon Medical Research Center, PCPortland, Oregon  97223
Suzanne Bruce and Associates, PA, The Center for Skin ResearchHouston, Texas  77056
The Education and Research FoundationLynchburg, Virginia  24501