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
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
1 other identifier
interventional
16
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 28, 2012
CompletedMarch 6, 2015
April 1, 2012
3 months
February 22, 2009
February 21, 2012
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels
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.
1 day
Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.
Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value.
1 day
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
Area under the blood conc. versus time curve was calculated for time 0-24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.
1 day
Secondary Outcomes (5)
Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area
baseline and day 57
Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area
Baseline and Day 57
Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.
baseline and Day 2, 3, 8, 15, 29 and 57
Patients With Incidence of Pigmentation and Scarring
Baseline, Day 2, 3, 8, 15, 29 and 57
Max Composite Local Skin Response (LSR) Score
Day 3
Study Arms (2)
PEP005 (ingenol mebutate) Gel, 0.05%
EXPERIMENTALVehicle Gel
PLACEBO COMPARATORInterventions
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Eligibility Criteria
You may qualify if:
- Male or female;
- Multiple actinic keratosis (AK) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (1)
DermResearch, Inc.
Austin, Texas, 78759, United States
Related Publications (1)
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.
PMID: 25584134DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Torsten Skov
- Organization
- LEO Pharma
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Jarratt, MD
Derm Research, PLLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2009
First Posted
February 26, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 6, 2015
Results First Posted
May 28, 2012
Record last verified: 2012-04