A Phase I, Single-centre, Open Label, Within-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Patients With Actinic Keratosis on the Upper Extremity

LEO Pharma1 site in 1 country27 target enrollmentAugust 2011

ConditionsActinic Keratosis

InterventionsPEP005 (Ingenol mebutat Gel, 0.05 %)

DrugsPEP005 (Ingenol mebutat Gel, 0.05 %)

Overview

Phase: Phase 1
Intervention: PEP005 (Ingenol mebutat Gel, 0.05 %)
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Enrollment: 27
Locations: 1
Primary Endpoint: Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

June 2012

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LEO Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients at least 18 years of age
•Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
•Patients with a 25 cm2 area of normal skin on the upper inner arm
•Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
•Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
•Ability to follow study instructions and likely to complete all study requirements
•Obtained written informed consent prior to any study-related procedures

Exclusion Criteria

•Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
•History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
•Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
•Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
•Current participation in any other interventional clinical trial
•Subjects who have received treatment with any non-marketed drug product within the last two months
•Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
•Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
•Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
•Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit