Phase 2 N=16 Randomized Triple-blind Treatment

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

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT00852137 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels — NA; NA ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PEP005 (ingenol mebutate) Gel, 0.05% (Drug); Vehicle Gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Peplin
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels	NA; NA	—
PRIMARY Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.	NA; NA	—
PRIMARY 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	NA; NA	—
SECONDARY Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area	10; 0	—
SECONDARY Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area	-96; 33	—
SECONDARY Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.	13; 1	—
SECONDARY Patients With Incidence of Pigmentation and Scarring	0; 0	—
SECONDARY Max Composite Local Skin Response (LSR) Score	6.6; 0	—

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00852137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.