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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-IIa)


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-IIa)


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:

Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.

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:

PEP005-016

NCT ID:

NCT00916006

Start Date:

June 2009

Completion Date:

September 2009

Related Keywords:

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

Name

Location

Dermatology Specialists IncVista, California  92083
Minnesota Clinical Study CenterFridley, Minnesota  55432
Center For Clinical StudiesHouston, Texas  77030
Virginia Clinical Research, IncNorfolk, Virginia  23507
Wake Research AssociatesRaleigh, North Carolina  27612
Dermatology Associates of TylerTyler, Texas  75703
Skin Surgery Medical Group Inc.5222 Balboa Avenue Sixth Floor, San Diego, California  
Dermatology Research AssociatesLos Angeles, California  90045
Hamzavi DermatologyFort Gratiot, Michigan  48059
Glazer DermatologyBuffalo Grove, Illinois  60089
Medaphase IncNewnan, Georgia  30263
Dermatology Research AssociatesNashville, Tennessee  37203
J & S Studies, Inc.College Station, Texas  77845
Conant Medical GroupSan Francisco, California  94114
University of Miami, Skin Research CampMiami, Florida  33136
Atlanta Dermatology, Vein & Research Center, LLCAlpharetta, Georgia  30022
Dawes Fretein Clinical Research Group, LLCIndianapolis, Indiana  46256
Pedia Research LLCOwensboro, Kentucky  42301
Dermatology Research Center, Inc.Salt Lake City, Utah  84124