Clinical trial NCT00700063: A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.


Eligibility criteria: Inclusion Criteria:

* Must be male or female
* Female patients must be of
* Non-childbearing potential;
* Childbearing potential, provided negative pregnancy test and using effective contraception
* 4 to 8 AK lesions on the face or scalp

Exclusion Criteria:

* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
* 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 2 cm of treatment area

Primary outcomes:
measure: Incidence of AEs Recorded Throughout the Study
timeFrame: 57 days
measure: Incidence of SAE Recorded Throughout the Study
timeFrame: 57 days
measure: Incidence Rate and Severity of LSRs Following Study Medication Application
timeFrame: Baseline
measure: Incidence Rate and Severity of LSRs Following Study Medication Application
timeFrame: Day 57
measure: Incidence of Hyperpigmentation Following Study Medication Application
timeFrame: Baseline
measure: Incidence of Hyperpigmentation Following Study Medication Application
timeFrame: Day 57
measure: Incidence of Hypopigmentation Following Study Medication Application
timeFrame: Baseline
measure: Incidence of Hypopigmentation Following Study Medication Application
timeFrame: Day 57
measure: Incidence of Scarring Following Study Medication Application
timeFrame: Baseline
measure: Incidence of Scarring Following Study Medication Application
timeFrame: Day 57
measure: Complete Clearance Rate of AK Lesions;
timeFrame: Day 57
Secondary outcomes:
measure: Efficacy (Clearance of AK Lesions) Partial Clearance Rate
timeFrame: 57 days
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: Koppel Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Riverside
country: United States
facility: Integrated Research Group Inc
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc
state: California
city: San Francisco
country: United States
facility: 470 Castro St Suite 202-204
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Vista
country: United States
facility: Dermatology Specialists Inc
state: California
city: St Petersburg
country: United States
facility: Spencer Derm and Skin Surgery Center
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trial
state: Idaho
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler
state: Texas
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Brisbane
country: Australia
facility: Siller Medical
state: Queensland
Study officials:
References: