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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)

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PEP005 Topical Gel
PEP005 Topical Gel
PEP005 Topical Gel
Vehicle gel
PEP005 Topical Gel
PEP005 Topical Gel
PEP005 Topical Gel
Vehicle 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, Actinic keratosis, PEP005

Eligibility Criteria

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

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

Sites / Locations

  • Burke Pharmaceutical Research
  • Dermatology Research of Arkansas
  • Koppel Dermatology
  • Dermatology Research Associates
  • Integrated Research Group Inc
  • Skin Surgery Medical Group Inc
  • 470 Castro St Suite 202-204
  • Solano Clinical Research
  • Dermatology Specialists Inc
  • Spencer Derm and Skin Surgery Center
  • Northwest Clinical Trial
  • Altman Dermatology Associates
  • Christie Clinic
  • South Bend Clinic
  • Minnesota Clinical Study Center
  • TKL Research, Inc.
  • Academic Dermatology Associates
  • Oregon Medical Research Center
  • Philadelphia Institute of Dermatology
  • Dermatology Research Associates
  • DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
  • Suzanne Bruce and Associates, The Center for Skin Research
  • Dermatology Clinical Research Center of San Antonio
  • Progressive Clinical Research
  • Dermatology Associates of Tyler
  • Southderm Pty Ltd
  • The Skin Centre
  • Siller Medical

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

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Outcomes

Primary Outcome Measures

Incidence of AEs Recorded Throughout the Study
Incidence of AEs recorded throughout the study
Incidence of SAE Recorded Throughout the Study
Incidence of SAE recorded throughout the study
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.
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.
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.
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)
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)
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)
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)
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).
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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2008
Last Updated
March 24, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00700063
Brief Title
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)
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Arm Title
8
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.005%, two days treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.01%, two days treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.015%, two days treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Intervention Description
two days treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.005%, three days treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.01%, three days treatment
Intervention Type
Drug
Intervention Name(s)
PEP005 Topical Gel
Intervention Description
0.015%, three days treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Intervention Description
three days treatment
Primary Outcome Measure Information:
Title
Incidence of AEs Recorded Throughout the Study
Description
Incidence of AEs recorded throughout the study
Time Frame
57 days
Title
Incidence of SAE Recorded Throughout the Study
Description
Incidence of SAE recorded throughout the study
Time Frame
57 days
Title
Incidence Rate and Severity of LSRs Following Study Medication Application
Description
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.
Time Frame
Baseline
Title
Incidence Rate and Severity of LSRs Following Study Medication Application
Description
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.
Time Frame
Day 57
Title
Incidence of Hyperpigmentation Following Study Medication Application
Description
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Time Frame
Baseline
Title
Incidence of Hyperpigmentation Following Study Medication Application
Description
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)
Time Frame
Day 57
Title
Incidence of Hypopigmentation Following Study Medication Application
Description
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)
Time Frame
Baseline
Title
Incidence of Hypopigmentation Following Study Medication Application
Description
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)
Time Frame
Day 57
Title
Incidence of Scarring Following Study Medication Application
Description
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)
Time Frame
Baseline
Title
Incidence of Scarring Following Study Medication Application
Description
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).
Time Frame
Day 57
Title
Complete Clearance Rate of AK Lesions;
Description
Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Time Frame
Day 57
Secondary Outcome Measure Information:
Title
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Description
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
Time Frame
57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
Facility Name
Dermatology Research of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Koppel Dermatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
70072
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Integrated Research Group Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92506
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
470 Castro St Suite 202-204
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Dermatology Specialists Inc
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Spencer Derm and Skin Surgery Center
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Northwest Clinical Trial
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
TKL Research, Inc.
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Suzanne Bruce and Associates, The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Associates of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Siller Medical
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/
Description
Food and Drug Authority
URL
http://www.tga.gov.au/
Description
Therapeutic Goods Administration

Learn more about this trial

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)

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