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Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PEP005 Topical gel
Sponsored by
Peplin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Peplin, PEP005, Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be male and at least 18 years of age.
  • A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion Criteria:

  • Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
  • 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 within 2 cm of the selected treatment area(s).

Sites / Locations

  • Radiant Research
  • Skin Surgery Medical Group Inc.
  • Park Avenue Dermatology
  • Advanced Dermatology and Cosmetic Surgery
  • Radiant Research Inc.
  • Medaphase Inc
  • Karen S. Harkaway, MD LLC
  • J&S Studies
  • St George Dematology and Skin and Cancer Centre
  • South East Dermatology, Belmont Specialist Centre
  • Skin and Cancer Foundation
  • St John of God Dermatology
  • Burswood Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Cohort 1 One 25 cm2 treatment area; on one arm

Cohort 2 One 50cm2 contiguous treatment area; on one arm

Cohort 3 Two 25cm2 treatment areas; one on each arm

Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm

Cohort 5 One 75cm2 contiguous treatment area; on one arm

Cohort 6 Two 50cm2 contiguous treatment area; one on each arm

Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm

Cohort 8 One 100cm2 contiguous treatment area; on one arm

Outcomes

Primary Outcome Measures

Safety and tolerability (incidence of AEs, SAEs and skin responses)

Secondary Outcome Measures

Full Information

First Posted
April 15, 2008
Last Updated
September 11, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00659893
Brief Title
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Official Title
A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peplin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Peplin, PEP005, Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cohort 1 One 25 cm2 treatment area; on one arm
Arm Title
2
Arm Type
Experimental
Arm Description
Cohort 2 One 50cm2 contiguous treatment area; on one arm
Arm Title
3
Arm Type
Experimental
Arm Description
Cohort 3 Two 25cm2 treatment areas; one on each arm
Arm Title
4
Arm Type
Experimental
Arm Description
Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm
Arm Title
5
Arm Type
Experimental
Arm Description
Cohort 5 One 75cm2 contiguous treatment area; on one arm
Arm Title
6
Arm Type
Experimental
Arm Description
Cohort 6 Two 50cm2 contiguous treatment area; one on each arm
Arm Title
7
Arm Type
Experimental
Arm Description
Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm
Arm Title
8
Arm Type
Experimental
Arm Description
Cohort 8 One 100cm2 contiguous treatment area; on one arm
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical gel
Intervention Description
0.05%, two day dose
Primary Outcome Measure Information:
Title
Safety and tolerability (incidence of AEs, SAEs and skin responses)
Time Frame
Screening to End of Study (Day 57)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be male and at least 18 years of age. A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions. Exclusion Criteria: Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s). 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 within 2 cm of the selected treatment area(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Schmieder, DO
Organizational Affiliation
Park Avenue Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Shumack, MD
Organizational Affiliation
St George Dermatology and Skin and Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Skin Surgery Medical Group Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Radiant Research Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Medaphase Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Karen S. Harkaway, MD LLC
City
Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
St George Dematology and Skin and Cancer Centre
City
Kogarah, Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
South East Dermatology, Belmont Specialist Centre
City
Carina Heights, Brisbane
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Skin and Cancer Foundation
City
Carlton, Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
St John of God Dermatology
City
Subiaco, Perth
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park, Perth
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25584134
Citation
Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.
Results Reference
derived
Links:
URL
http://www.fda.gov
Description
Food and Drug Administration
URL
http://www.tga.gov.au/
Description
Therapeutic Goods Administration

Learn more about this trial

Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

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