Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

NCT00375739 | Completed Phase 2

• 1 other identifier: PEP005-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Topical; Solar Keratosis; Sun Spots; Dermatology

Outcome Measures

Primary Outcomes (1)

• Safety

Secondary Outcomes (1)

• Resolution of AK

Interventions

PEP005 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients at least 18 years of age.
• Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
• to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
• Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.
• Ability to follow study instructions and likely to complete all study requirements.
• Written informed consent has been obtained.
• Written Authorization for Use and Release of Health and Research Study Information has been obtained.
• Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.

You may not qualify if:

• Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
• Location of the selected AK treatment area:
• anywhere on the face
• within 5 cm of an incompletely healed wound
• on the breast area of women
• on the dorsum of the hand
• AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
• Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.
• Presence of known or suspected metastatic disease.
• History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
• Known sensitivity to any of the ingredients in the study drug.
• A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):
• within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
• Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic therapy:
• within 2 cm of the selected AK treatment area during the 24 months prior to screening visit or

Sponsors & Collaborators

• Peplin: lead

Study Sites (24)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Radiant Research

Tucson, Arizona, 85710, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Advanced Dermatology and Cosmetic Surgery

Clermont, Florida, 34711, United States

Location

Dermatology Associates and Research

Coral Gales, Florida, 33134, United States

Location

North Florida Dermatology Associates P.A.

Jacksonville, Florida, 32204, United States

Location

Park Avenue Dermatology, PA

Orange Park, Florida, 32073, United States

Location

Dermatology Associates of Tallahassee

Tallahassee, Florida, 32308, United States

Location

Palm Beach Aesthetics

West Palm Beach, Florida, 33401, United States

Location

Medaphase, Inc

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Centre, Inc

Snellville, Georgia, 30078-3250, United States

Location

Henry Ford Health Center- Farmington Road

West Bloomfield, Michigan, 48322, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106-5239, United States

Location

St. Luke's/Roosevelt Hospital Center Dermatology

New York, New York, 10025, United States

Location

Mount Sinai Hospital School of Medicine

New York, New York, 10029, United States

Location

University Dermatology Consultants, Inc., Dermatology Clinical Research Center

Cincinnati, Ohio, 45219-4215, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Oregon Medical Research

Centre9495 Southwest Locust St., Suite G Portland, Oregon, 97223, United States

Location

Radiant Research

Anderson, South Carolina, 29621, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229-3409, United States

Location

Dermatology Associates of Tyler

Tyler, Texas, 75703, United States

Location

Dermatology Research Centre

Salt Lake City, Utah, 84124, United States

Location

Skokane Dermatology Clinic, PLLP.

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic; Melanosis

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Hyperpigmentation; Pigmentation Disorders

Study Officials

• Lawrence Anderson, Dr

  PRINCIPAL INVESTIGATOR

• Peter Welburn, PhD

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 13, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (24)