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)
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)
1 other identifier
interventional
265
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 15, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
August 22, 2012
CompletedApril 14, 2015
March 1, 2015
4 months
June 15, 2008
June 13, 2012
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Incidence of AEs Recorded Throughout the Study
Incidence of AEs recorded throughout the study
57 days
Incidence of SAE Recorded Throughout the Study
Incidence of SAE recorded throughout the study
57 days
Incidence Rate and Severity of LSRs Following Study Medication Application
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.
Baseline
Incidence Rate and Severity of LSRs Following Study Medication Application
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.
Day 57
Incidence of Hyperpigmentation Following Study Medication Application
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Baseline
Incidence of Hyperpigmentation Following Study Medication Application
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)
Day 57
Incidence of Hypopigmentation Following Study Medication Application
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)
Baseline
Incidence of Hypopigmentation Following Study Medication Application
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)
Day 57
Incidence of Scarring Following Study Medication Application
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)
Baseline
Incidence of Scarring Following Study Medication Application
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).
Day 57
Complete Clearance Rate of AK Lesions;
Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Day 57
Secondary Outcomes (1)
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
57 days
Study Arms (8)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATOR5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTAL8
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Must be male or female
- Female patients must be of
- Non-childbearing potential;
- Childbearing potential, provided negative pregnancy test and using effective contraception
- to 8 AK lesions on the face or scalp
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (28)
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913, United States
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205, United States
Koppel Dermatology
Los Angeles, California, 70072, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Integrated Research Group Inc
Riverside, California, 92506, United States
Skin Surgery Medical Group Inc
San Diego, California, 92117, United States
470 Castro St Suite 202-204
San Francisco, California, 94114, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Dermatology Specialists Inc
Vista, California, 92083, United States
Spencer Derm and Skin Surgery Center
St. Petersburg, Florida, 33716, United States
Northwest Clinical Trial
Boise, Idaho, 83704, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Christie Clinic
Champaign, Illinois, 61820, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
TKL Research, Inc.
Paramus, New Jersey, 07652, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Philadelphia Institute of Dermatology
Philadelphia, Pennsylvania, 19034, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
Austin, Texas, 78759, United States
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Dermatology Associates of Tyler
Tyler, Texas, 75703, United States
Southderm Pty Ltd
Kogarah, New South Wales, 2217, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Siller Medical
Brisbane, Queensland, 4000, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure Manager
- Organization
- Leo Pharma A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
April 14, 2015
Results First Posted
August 22, 2012
Record last verified: 2015-03