Clinical trial NCT00659893: Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Official title: A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Peplin
PEP005
Actinic Keratosis
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.


Eligibility criteria: Inclusion Criteria:

* Must be male and at least 18 years of age.
* A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion Criteria:

* Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): 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: Safety and tolerability (incidence of AEs, SAEs and skin responses)
timeFrame: Screening to End of Study (Day 57)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc.
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research Inc.
state: Florida
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Delran
country: United States
facility: Karen S. Harkaway, MD LLC
state: New Jersey
city: College Station
country: United States
facility: J&S Studies
state: Texas
city: Kogarah, Sydney
country: Australia
facility: St George Dematology and Skin and Cancer Centre
state: New South Wales
city: Carina Heights, Brisbane
country: Australia
facility: South East Dermatology, Belmont Specialist Centre
state: Queensland
city: Carlton, Melbourne
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
city: Subiaco, Perth
country: Australia
facility: St John of God Dermatology
state: Western Australia
city: Victoria Park, Perth
country: Australia
facility: Burswood Dermatology
state: Western Australia
Study officials:
affiliation: Park Avenue Dermatology
name: George Schmieder, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: St George Dermatology and Skin and Cancer Centre
name: Stephen Shumack, 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.