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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-Ib)


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-Ib)


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:

Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions

Outcome Description:

Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area

Outcome Time Frame:

57 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-028

NCT ID:

NCT00942604

Start Date:

July 2009

Completion Date:

October 2009

Related Keywords:

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

Name

Location

Virginia Clinical Research, IncNorfolk, Virginia  23507
Dawes Fretzin Clinical Research Group, LLCIndianapolis, Indiana  46256
Dermatology Clinical Research Center of San AntonioSan Antonio, Texas  78229
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Dermatology Associates of TylerTyler, Texas  75703
Skin Surgery Medical Group Inc.5222 Balboa Avenue Sixth Floor, San Diego, California  
Glazer DermatologyBuffalo Grove, Illinois  60089
Burke Pharmaceutical ResearchHot Springs, Arizona  71913
Skin Specialists, PCOmaha, Nebraska  
Karl G. Heine DermatologyHenderson, Nevada  89002
Suzanne Bruce and Associates, PA, The Center for Skin ResearchHouston, Texas  77056
The Education and Research FoundationLynchburg, Virginia  24501
Atlanta Dermatology, Vein & Research Center, LLCAlpharetta, Georgia  30022
Dermatology Research Center, Inc.Salt Lake City, Utah  84124
Deaconess Clinic DowntownEvansville, Indiana  47713
Group Health AssociatesCincinnati, Ohio  45220