Keratosis Clinical Trial
Official title:
An Open-label, Dose Escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel When Applied on Day 1 and Day 2 to Actinic Keratoses on the Shoulders, Chest, Back or Arms Followed by a Post-Treatment Follow-up Period Lasting at Four Weeks
The purpose of this study is :
- To determine the maximum tolerated dose (MTD) for PEP005 Topical Gel in patients with
actinic keratoses.
- To evaluate patients for clinical safety
- To determine the systemic absorption of PEP005 Topical Gel
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or
sores on the top layer of the skin which if left untreated can progress to skin cancer.
Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long
treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus
being researched.
This is an open label, dose escalation, cohort study to determine the maximum tolerated dose
(MTD) of PEP005 Topical Gel, administered once daily for two consecutive days (90 ul gel
applied topically over a 3 x 3cm template surrounding a target lesion), to patients with
actinic keratoses (AK). The study will be conducted in one centre in the US. Three patients
will be entered initially at the lowest dose level (0.01%) with up to an additional three
patients to be entered in the event of a dose limiting toxicity (DLT) in the initial
patients. DLT are defined as 'severe' local skin reactions observed by the Investigator,
either prior to treatment on Day 2 ( following treatment on Day 1 ) or observed on Day 8
(following treatment on Day 2). Based on findings from phase I studies and the low systemic
absorption found in non-clinical toxicokinetic evaluations, no systemic toxicity is
anticipated.Once determined A total of 10 patients will be treated at the MTD in order to
confirm it's determination. Based on findings from the phase I study, the starting dose will
be 0.01% PEP005 Gel.
Secondary objectives of the study are (1) evaluate the clinical efficiency of PEP005 Topical
Gel, when administered once daily for two consecutive days and (2) determine the systemic
absorption of PEP005 Topical Gel at the MTD . Hematologic and biochemical assessments will
be undertaken at the screening visit and at days 8 and 29 . Adverse events will be assessed
at every study visit. Clinical response to treatment will be assessed at Days 8, 15 and 29.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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