Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Superficial Basal Cell Carcinoma
2 other identifiers
interventional
60
1 country
9
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of superficial basal cell carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 14, 2005
CompletedFirst Posted
Study publicly available on registry
April 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 24, 2008
December 1, 2008
1 year
April 14, 2005
December 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Secondary Outcomes (1)
Efficacy
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients at least 18 years of age
- One sBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision
- Histological confirmation of sBCC based on the central dermatopathologist's evaluation of the punch biopsy
- Longest pre- and post-biopsy diameter of the sBCC lesion between 4 mm and 15 mm
- Maximum thickness of 4 mm of the sBCC lesion
- 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
- Male patients with a female partner of childbearing potential must use an approved form of contraception during the study and for 4 weeks after the last visit
- Agreement from the patient to allow photographs of all selected lesions (including the face) to be taken and used as part of the study data package
You may not qualify if:
- Location of the outside margin of the anticipated treatment area of the sBCC selected for treatment:
- within 10 cm of a malignant lesion that will require treatment during the study
- within 5 cm of an incompletely healed wound
- within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion)
- within 2 cm of the open eyelid margins
- within 1 cm of a scar or an area previously treated with surgical excision
- on the lips
- on the breast
- on the hand or foot
- in a skin crease
- sBCC lesion selected for treatment requiring Mohs micrographic surgery
- Presence of known or suspected metastatic disease
- Histological evidence of actinic keratoses or nBCC in the screening visit biopsy sample
- Histological evidence of BCC with micro-nodular features or squamous metaplasia, sclerosing BCC (i.e. desmoplastic or morphoeic), or BCC with perineural involvement in the screening visit biopsy sample
- History of recurrence of the sBCC lesion
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (9)
Southderm Pty Ltd
Sydney, New South Wales, 2010, Australia
St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, 2217, Australia
Siller Medical
Brisbane, Queensland, 4000, Australia
Belmont Specialist Centre
Brisbane, Queensland, 4152, Australia
The Skin Centre
Gold Coast, Queensland, 4217, Australia
Skin and Cancer Foundation
Melbourne, Victoria, 3053, Australia
Freemantle Dermatology
Freemantle, Western Australia, 6160, Australia
Private Dermaology Clinic
Fremantle, Western Australia, 6160, Australia
St John of God Dermatology
Subiaco, Western Australia, 6008, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg Siller
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 14, 2005
First Posted
April 15, 2005
Study Start
March 1, 2005
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
December 24, 2008
Record last verified: 2008-12