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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00108121




Registration number
NCT00108121
Ethics application status
Date submitted
14/04/2005
Date registered
15/04/2005
Date last updated
19/01/2015

Titles & IDs
Public title
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma
Scientific title
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 Nodular Basal Cell Carcinoma
Secondary ID [1] 0 0
2005/153
Secondary ID [2] 0 0
PEP005-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Resolution of nodular basal cell carcinoma
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Male or female patients at least 18 years of age
* One nBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision
* Histological confirmation of nBCC based on the central dermatopathologist's evaluation of the punch biopsy
* Longest pre- and post-biopsy diameter of the nBCC lesion between 4 mm and 15 mm
* Maximum thickness of 4 mm of the nBCC 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Location of the outside margin of the anticipated treatment area of the nBCC selected for treatment:

1. within 10 cm of a malignant lesion that will require treatment during the study
2. within 5 cm of an incompletely healed wound
3. within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion)
4. within 2 cm of the open eyelid margins
5. within 1 cm of a scar or an area previously treated with surgical excision
6. on the lips
7. on the breast
8. on the hand or foot
9. in a skin crease
* nBCC lesion selected for treatment requiring Mohs micrographic surgery
* Presence of known or suspected metastatic disease
* Histological evidence of actinic keratoses or sBCC (superficial basal cell carcinoma) 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 nBCC lesion
* History or evidence of skin diseases which would interfere with evaluation of the treatment area (e.g. eczema, unstable psoriasis, xeroderma pigmentosa)
* Known sensitivity to any of the ingredients in the study medication
* A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or anticipated treatment within 10 cm of the selected lesion during the study
* Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

1. of lesions located within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or
2. anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
* Use of acid-containing products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or anticipated treatment in this same area during the study
* Treatment with immuno-modulators (e.g. cyclosporine, prednisone, methotrexate, infliximab or other biological agents), cytotoxic drugs (e.g. vinblastine, cyclophosphamide, azathioprine, chlorambucil, methotrexate), or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
* Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
* Use of systemic retinoids (e.g. isotretinoin, acitretin) during the 6 months prior to study entry or anticipated treatment during the study
* Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds) or use of topical salves, creams or ointments to the selected lesion during the study
* Anticipated need for hospitalization or non-dermatological surgery during the study
* Concurrent disease that suppresses the immune system (e.g. HIV) or uncontrolled systemic disease (e.g. uncontrolled hypertension, poorly controlled diabetes)
* Current evidence of chronic alcohol or drug abuse
* Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Diagnosis of xeroderma pigmentosa or Gorlin Syndrome (i.e. Basal Cell Nevus Syndrome)
* A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
* 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Southderm Pty Ltd - Sydney
Recruitment hospital [2] 0 0
St George Dermatology & Skin Cancer Centre - Sydney
Recruitment hospital [3] 0 0
Siller Medical - Brisbane
Recruitment hospital [4] 0 0
South East Dermatology - Brisbane
Recruitment hospital [5] 0 0
The Skin Centre - Gold Coast
Recruitment hospital [6] 0 0
13 Eleanor St - Footscray
Recruitment hospital [7] 0 0
Skin and Cancer Foundation - Melbourne
Recruitment hospital [8] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [9] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [10] 0 0
St John of God Dermatology - Subiaco
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
4000 - Brisbane
Recruitment postcode(s) [4] 0 0
4152 - Brisbane
Recruitment postcode(s) [5] 0 0
4217 - Gold Coast
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3052 - Melbourne
Recruitment postcode(s) [8] 0 0
3168 - Melbourne
Recruitment postcode(s) [9] 0 0
6160 - Fremantle
Recruitment postcode(s) [10] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Peplin
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.
Trial website
https://clinicaltrials.gov/study/NCT00108121
Trial related presentations / publications
Rosen RH, Katsamas J, Ogbourne SM, Welburn P. Early phase clinical development of PEP005 topical gel for basal cell carcinoma. 21st World Congress of Dermatology, Buenos Aires, 2007. 2007: Poster no. P5755 (1 p.)
Rosen RH, Freeman M, Siller G, Katsamas J, Ogbourne SM. Safety and efficacy of PEP005 Topical Gel for the treatment of nodular and superficial forms of basal cell carcinoma. Summer Academy, American Academy of Dermatology meeting, New York, NY, 2007. 2007: Poster no. P1502
Public notes

Contacts
Principal investigator
Name 0 0
Greg Siller
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00108121