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A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)


Inclusion Criteria:



- Must be male or female

- Female patients must be of

- Non-childbearing potential;

- Childbearing potential, provided negative pregnancy test and using effective
contraception

- 4 to 8 AK lesions on the face or scalp

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

Outcome Measure:

Incidence of AEs Recorded Throughout the Study

Outcome Description:

Incidence of AEs recorded throughout the study

Outcome Time Frame:

57 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-015

NCT ID:

NCT00700063

Start Date:

June 2008

Completion Date:

October 2008

Related Keywords:

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

Name

Location

South Bend ClinicSouth Bend, Indiana  46617
Solano Clinical ResearchVallejo, California  94589
Dermatology Specialists IncVista, California  92083
Minnesota Clinical Study CenterFridley, Minnesota  55432
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Christie ClinicChampaign, Illinois  61820
Dermatology Clinical Research Center of San AntonioSan Antonio, Texas  78229
Oregon Medical Research CenterPortland, Oregon  97223
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Dermatology Associates of TylerTyler, Texas  75703
Dermatology Research AssociatesLos Angeles, California  90045
Philadelphia Institute of DermatologyFort Washington, Pennsylvania  19034
Skin Surgery Medical Group Inc5222 Balboa Avenue Sixth Floor San Diego, California  92117
Progressive Clinical ResearchSan Antonio, Texas  78229
Burke Pharmaceutical ResearchHot Springs, Arizona  71913
Dermatology Research of ArkansasLittle Rock, Arkansas  72205
Koppel DermatologyLos Angeles, California  70072
Integrated Research Group IncRiverside, California  92506
470 Castro St Suite 202-204San Francisco, California  94114
Spencer Derm and Skin Surgery CenterSt Petersburg, Florida  33716
Northwest Clinical TrialBoise, Idaho  83704
TKL Research, Inc.Paramus, New Jersey  07652
Dermatology Research AssociatesNashville, Tennessee  37203
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,Austin, Texas  78759
Suzanne Bruce and Associates, The Center for Skin ResearchHouston, Texas  77056