Clinical trial NCT00852137: A 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Peplin
PEP005
Actinic Keratosis
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study is designed 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 keratoses


Eligibility criteria: 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).

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels
timeFrame: 1 day
measure: Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.
timeFrame: 1 day
measure: Area Under the Blood Conc. Versus Time Curve for Time 0-24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels
timeFrame: 1 day
Secondary outcomes:
measure: Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area
timeFrame: baseline and day 57
measure: Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area
timeFrame: Baseline and Day 57
measure: Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.
timeFrame: baseline and Day 2, 3, 8, 15, 29 and 57
measure: Patients With Incidence of Pigmentation and Scarring
timeFrame: Baseline, Day 2, 3, 8, 15, 29 and 57
measure: Max Composite Local Skin Response (LSR) Score
timeFrame: Day 3
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Derm Research, PLLC
name: Michael Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.