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A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)


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

Thank you

Trial Information

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)


Inclusion Criteria:



- Patient is male or female and at least 18 years of age.

- Female patient must be of either:

- Non-childbearing potential, post-menopausal, or there is a confirmed clinical
history of sterility (e.g., the patient is without a uterus)

- Childbearing potential, provided there are negative urine pregnancy test results
prior to study treatment, to rule out pregnancy

Exclusion Criteria

- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected
treatment area.

- Treatment with immunomodulators, 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)

Outcome Time Frame:

57 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-020

NCT ID:

NCT00917306

Start Date:

June 2009

Completion Date:

September 2009

Related Keywords:

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

Name

Location

Henry Ford Health SystemsDetroit, Michigan  48202
Oregon Health and Science UniversityPortland, Oregon  97201
Park Avenue DermatologyOrange Park, Florida  32073
Dermatology Associates of RochesterRochester, New York  14623
Gwinnett Clinical Research Centre2383 Pate St, Snellville, Georgia  30078-3250
Medaphase IncNewnan, Georgia  30263
Dermatology Research AssociatesNashville, Tennessee  37203
Michigan Center for Research CorpClinton Twp, Michigan  48038