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Basal Cell CarcinomaPhase 2NCT00108121

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma

A Phase 2 study testing PEP005 in people with Basal Cell Carcinoma, run by Peplin at 10 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
PEP005
How many people
60 participants
Where
10 sitesAustralia
Study dates
Mar 2005to May 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Location of the outside margin of the anticipated treatment area of the nBCC 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
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  • on the lips
  • on the breast
  • on the hand or foot
  • 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:
  • of lesions located within 10 cm of the selected nBCC lesion during the 3 months prior to study entry or
  • 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)

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Australia10 sites

  • Siller Medical

    Brisbane, Queensland, 4000

  • South East Dermatology

    Brisbane, Queensland, 4152

  • 13 Eleanor St

    Footscray, Victoria, 3011

  • Fremantle Dermatology

    Fremantle, Western Australia, 6160

  • The Skin Centre

    Gold Coast, Queensland, 4217

  • Skin and Cancer Foundation

    Melbourne, Victoria, 3052

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • St John of God Dermatology

    Subiaco, Western Australia, 6008

  • Southderm Pty Ltd

    Sydney, New South Wales, 2010

  • St George Dermatology & Skin Cancer Centre

    Sydney, New South Wales, 2217

Other trials in Australia

About this study

Official 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

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.

Read the detailed description

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 nBCC (nodular basal cell carcinoma) 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.

Being tested
PEP005
Keywords
Nodular basal cell carcinoma, basal cell carcinoma, nBCC, BCC, PEP005, Topical, Dermatology
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEP005Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

Secondary outcomes (1)

  1. Resolution of nodular basal cell carcinoma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108121
Sponsor's protocol ID
PEP005-002
Other IDs
2005/153
Status last verified
Jan 2015
First submitted
14 Apr 2005
Last updated
19 Jan 2015
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEP005 in people with Basal Cell Carcinoma, run by Peplin at 10 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00108121, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.

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