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)

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: PEP005 Topical Gel; Drug: PEP005 Topical Gel; Drug: PEP005 Topical Gel; Drug: PEP005 Topical Gel; Drug: PEP005 Topical Gel; Drug: PEP005 Topical Gel; Drug: Vehicle gel; Drug: Vehicle gel

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Southderm Pty Ltd
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Brisbane, Queensland, Australia, 4000
      • Siller Medical
• United States
  • Arizona
    • Hot Springs, Arizona, United States, 71913
      • Burke Pharmaceutical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Dermatology Research of Arkansas
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 70072
      • Koppel Dermatology
    • Riverside, California, United States, 92506
      • Integrated Research Group Inc
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group Inc
    • San Francisco, California, United States, 94114
      • 470 Castro St Suite 202-204
    • Vallejo, California, United States, 94589
      • Solano Clinical Research
    • Vista, California, United States, 92083
      • Dermatology Specialists Inc
  • Florida
    • St Petersburg, Florida, United States, 33716
      • Spencer Derm and Skin Surgery Center
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trial
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
    • Champaign, Illinois, United States, 61820
      • Christie Clinic
  • Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Dermatology Research Associates
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • Tyler, Texas, United States, 75703
      • Dermatology Associates of Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Experimental: 2	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Experimental: 3	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Placebo Comparator: 4	Drug: Vehicle gel; two days treatment; Drug: Vehicle gel; three days treatment
Experimental: 5	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Experimental: 6	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Experimental: 7	Drug: PEP005 Topical Gel; 0.005%, two days treatment; Drug: PEP005 Topical Gel; 0.01%, two days treatment; Drug: PEP005 Topical Gel; 0.015%, two days treatment; Drug: PEP005 Topical Gel; 0.005%, three days treatment; Drug: PEP005 Topical Gel; 0.01%, three days treatment; Drug: PEP005 Topical Gel; 0.015%, three days treatment
Placebo Comparator: 8	Drug: Vehicle gel; two days treatment; Drug: Vehicle gel; three days treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy (Clearance of AK Lesions) Partial Clearance Rate	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	57 days

Collaborators and Investigators

• Sponsor: Peplin

Publications and helpful links

Helpful Links

• Food and Drug Authority
• Therapeutic Goods Administration

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 15, 2008
• First Submitted That Met QC Criteria: June 17, 2008
• First Posted (Estimate): June 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Actinic keratosis; Peplin; PEP005
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PEP005-015