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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

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


Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun
exposure. Current treatments include surgery, curettage/desiccation and simple excision,
which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of
BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for
many years in Australia as a "folk" remedy to treat a number of skin conditions. The active
component of Euphorbia peplus has been isolated and made into a gel applied directly to the
skin by Peplin Ltd. To date, only one well-controlled study with PEP005 gel in humans has
been completed. Sixteen patients received a single application of PEP005 0.01% or vehicle
gel to actinic keratoses on the chest, shoulders, back and/or arms. Results show good
tolerance and evidence of activity. The current study is designed to evaluate the safety of
two applications of PEP005 gel in patients with superficial basal cell carcinoma (sBCC) on
the arms, shoulders, chest, face and/or scalp, testing three concentrations according to two
treatment regimens. Approximately 60 patients are planned to be included from multiple
Australian centers. Efficacy and cosmetic outcome will be assessed and a recommended
treatment regimen will be determined. Assignment to treatment is random and patients and
medical staff will be blinded as to the treatment. Patients will have two visits for
treatment application and will return for check-up visits the day after the first
application and several times thereafter for approximately 3 months.


Inclusion Criteria:



- 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

Exclusion Criteria:

- Location of the outside margin of the anticipated treatment area of the sBCC 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

- 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

- 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 sBCC 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 sBCC 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 sBCC 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Safety

Principal Investigator

Greg Siller

Investigator Role:

Principal Investigator

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PEP005-003

NCT ID:

NCT00108134

Start Date:

March 2005

Completion Date:

March 2006

Related Keywords:

  • Basal Cell Carcinoma
  • Superficial basal cell carcinoma
  • basal cell carcinoma
  • sBCC
  • BCC
  • PEP005
  • Topical
  • Dermatology
  • Carcinoma
  • Carcinoma, Basal Cell

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