NCT00659893

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1

Geographic Reach
2 countries

13 active sites

Status
completed

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

April 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 14, 2015

Status Verified

November 1, 2008

Enrollment Period

7 months

First QC Date

April 15, 2008

Last Update Submit

September 11, 2015

Conditions

Actinic Keratosis

Keywords

PeplinPEP005Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

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

    Screening to End of Study (Day 57)

Study Arms (8)

1

EXPERIMENTAL

Cohort 1 One 25 cm2 treatment area; on one arm

Drug: PEP005 Topical gel

2

EXPERIMENTAL

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

Drug: PEP005 Topical gel

3

EXPERIMENTAL

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

Drug: PEP005 Topical gel

4

EXPERIMENTAL

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

Drug: PEP005 Topical gel

5

EXPERIMENTAL

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

Drug: PEP005 Topical gel

6

EXPERIMENTAL

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

Drug: PEP005 Topical gel

7

EXPERIMENTAL

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

Drug: PEP005 Topical gel

8

EXPERIMENTAL

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

Drug: PEP005 Topical gel

Interventions

PEP005 Topical gelDRUG

0.05%, two day dose

12345678

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Radiant Research

Tucson, Arizona, 85710, United States

Location

Skin Surgery Medical Group Inc.

San Diego, California, 92117, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, 32174, United States

Location

Radiant Research Inc.

Pinellas Park, Florida, 33781, United States

Location

Medaphase Inc

Newnan, Georgia, 30263, United States

Location

Karen S. Harkaway, MD LLC

Riverside Park, New Jersey, 08075, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

St George Dematology and Skin and Cancer Centre

Kogarah, Sydney, New South Wales, 2217, Australia

Location

South East Dermatology, Belmont Specialist Centre

Carina Heights, Brisbane, Queensland, 4152, Australia

Location

Skin and Cancer Foundation

Carlton, Melbourne, Victoria, 3053, Australia

Location

St John of God Dermatology

Subiaco, Perth, Western Australia, 6008, Australia

Location

Burswood Dermatology

Victoria Park, Perth, Western Australia, 6100, Australia

Location

Related Publications (1)

  • 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.

    PMID: 25584134DERIVED

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • George Schmieder, DO

    Park Avenue Dermatology

    PRINCIPAL INVESTIGATOR

  • Stephen Shumack, MD

    St George Dermatology and Skin and Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 14, 2015

Record last verified: 2008-11

Locations

US(8)AU(5)