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A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis


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

Thank you

Trial Information

A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis


Inclusion Criteria:



- Male or female;

- Multiple actinic keratosis (AK) lesions over a 100 cm^2 area of skin located on the
dorsal aspect of one forearm.

Exclusion Criteria:

- Cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected
treatment area(s);

- 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 within 2 cm of the selected treatment area(s).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels

Outcome Description:

Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Michael Jarratt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

DermResearch, Inc

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-017

NCT ID:

NCT00852137

Start Date:

March 2009

Completion Date:

June 2009

Related Keywords:

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

Name

Location
DermResearch, Inc. Austin, Texas  78759