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)
- Conditions
- Actinic Keratosis
- Interventions
- Drug: PEP005 Topical GelDrug: Vehicle gel
- Registration Number
- NCT00700063
- Lead Sponsor
- Peplin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7 PEP005 Topical Gel - 2 PEP005 Topical Gel - 4 Vehicle gel - 5 PEP005 Topical Gel - 6 PEP005 Topical Gel - 1 PEP005 Topical Gel - 3 PEP005 Topical Gel - 8 Vehicle gel -
- Primary Outcome Measures
Name Time Method Incidence of AEs Recorded Throughout the Study 57 days Incidence of AEs recorded throughout the study
Incidence of SAE Recorded Throughout the Study 57 days Incidence of SAE recorded throughout the study
Incidence of Hyperpigmentation Following Study Medication Application Day 57 The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence of Hypopigmentation Following Study Medication Application Day 57 The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence Rate and Severity of LSRs Following Study Medication Application Day 57 The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized.Incidence of Scarring Following Study Medication Application Day 57 The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).
Complete Clearance Rate of AK Lesions; Day 57 Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
- Secondary Outcome Measures
Name Time Method Efficacy (Clearance of AK Lesions) Partial Clearance Rate 57 days Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp
Trial Locations
- Locations (27)
Dermatology Research of Arkansas
🇺🇸Little Rock, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arizona, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
TKL Research, Inc.
🇺🇸Paramus, New Jersey, United States
Spencer Derm and Skin Surgery Center
🇺🇸St Petersburg, Florida, United States
Southderm Pty Ltd
🇦🇺Kogarah, New South Wales, Australia
Dermatology Specialists Inc
🇺🇸Vista, California, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Siller Medical
🇦🇺Brisbane, Queensland, Australia
Christie Clinic
🇺🇸Champaign, Illinois, United States
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Philadelphia Institute of Dermatology
🇺🇸Philadelphia, Pennsylvania, United States
Suzanne Bruce and Associates, The Center for Skin Research
🇺🇸Houston, Texas, United States
Koppel Dermatology
🇺🇸Los Angeles, California, United States
Skin Surgery Medical Group Inc
🇺🇸San Diego, California, United States
Solano Clinical Research
🇺🇸Vallejo, California, United States
Northwest Clinical Trial
🇺🇸Boise, Idaho, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Integrated Research Group Inc
🇺🇸Riverside, California, United States
470 Castro St Suite 202-204
🇺🇸San Francisco, California, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
🇺🇸Austin, Texas, United States
Dermatology Associates of Tyler
🇺🇸Tyler, Texas, United States