- ICH GCP
- US Clinical Trials Registry
- 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)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New South Wales
-
Kogarah, New South Wales, Australia, 2217
- Southderm Pty Ltd
-
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Queensland
-
Benowa, Queensland, Australia, 4217
- The Skin Centre
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Brisbane, Queensland, Australia, 4000
- Siller Medical
-
-
-
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Arizona
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Hot Springs, Arizona, United States, 71913
- Burke Pharmaceutical Research
-
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Dermatology Research of Arkansas
-
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California
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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Los Angeles, California, United States, 70072
- Koppel Dermatology
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Riverside, California, United States, 92506
- Integrated Research Group Inc
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San Diego, California, United States, 92117
- Skin Surgery Medical Group Inc
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San Francisco, California, United States, 94114
- 470 Castro St Suite 202-204
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Vallejo, California, United States, 94589
- Solano Clinical Research
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Vista, California, United States, 92083
- Dermatology Specialists Inc
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Florida
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St Petersburg, Florida, United States, 33716
- Spencer Derm and Skin Surgery Center
-
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Idaho
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Boise, Idaho, United States, 83704
- Northwest Clinical Trial
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Altman Dermatology Associates
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Champaign, Illinois, United States, 61820
- Christie Clinic
-
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Indiana
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South Bend, Indiana, United States, 46617
- South Bend Clinic
-
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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-
New Jersey
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Paramus, New Jersey, United States, 07652
- TKL Research, Inc.
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
-
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Oregon
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Portland, Oregon, United States, 97223
- Oregon Medical Research Center
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19034
- Philadelphia Institute of Dermatology
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Tennessee
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Nashville, Tennessee, United States, 37203
- Dermatology Research Associates
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Texas
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Austin, Texas, United States, 78759
- DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
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Houston, Texas, United States, 77056
- Suzanne Bruce and Associates, The Center for Skin Research
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San Antonio, Texas, United States, 78229
- Progressive Clinical Research
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San Antonio, Texas, United States, 78229
- Dermatology Clinical Research Center of San Antonio
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Tyler, Texas, United States, 75703
- Dermatology Associates of Tyler
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Experimental: 2
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Experimental: 3
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Placebo Comparator: 4
|
two days treatment
three days treatment
|
Experimental: 5
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Experimental: 6
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Experimental: 7
|
0.005%, two days treatment
0.01%, two days treatment
0.015%, two days treatment
0.005%, three days treatment
0.01%, three days treatment
0.015%, three days treatment
|
Placebo Comparator: 8
|
two days treatment
three days treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of AEs Recorded Throughout the Study
Time Frame: 57 days
|
Incidence of AEs recorded throughout the study
|
57 days
|
Incidence of SAE Recorded Throughout the Study
Time Frame: 57 days
|
Incidence of SAE recorded throughout the study
|
57 days
|
Incidence Rate and Severity of LSRs Following Study Medication Application
Time Frame: Baseline
|
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
Time Frame: 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. |
Day 57
|
Incidence of Hyperpigmentation Following Study Medication Application
Time Frame: Baseline
|
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
Time Frame: 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)
|
Day 57
|
Incidence of Hypopigmentation Following Study Medication Application
Time Frame: Baseline
|
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
Time Frame: 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)
|
Day 57
|
Incidence of Scarring Following Study Medication Application
Time Frame: Baseline
|
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
Time Frame: 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).
|
Day 57
|
Complete Clearance Rate of AK Lesions;
Time Frame: 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
|
Day 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Time Frame: 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
|
57 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP005-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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