AzTrials
AzTrials

Carcinoma, Squamous CellPhase 2NCT00329121

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ

A Phase 2 study testing PEP005 in people with Carcinoma, Squamous Cell, run by Peplin at 3 sites in Australia.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Squamous Cell
What is being tested?
PEP005
How many people
24 participants
Where
3 sitesAustralia
Study dates
May 2006to Dec 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 patients, at least 18 years of age.
  • Post-menopausal female patients, at least 18 years of age, i.e. no menses for at least 12 consecutive months, or without a uterus.
  • A primary, clinically diagnosed and histologically confirmed SCCIS lesion with the histological diagnosis being made within 90 days of the screening visit.
  • Longest diameter of the SCCIS lesion between 5 mm and 20 mm.
  • Ability to follow study instructions and likely to complete all study requirements.
  • Written informed consent has been obtained.
  • Written consent for tissue from the biopsy of the histologically confirmed SCCIS lesion to be examined and stored by the central dermatopathologist has been obtained.
  • Agreement from the patient to allow photographs of the selected SCCIS treatment area (including the face) to be used as part of the study data package.

Who cannot join

  • Females of childbearing potential (a female is considered of childbearing potential unless she is post-menopausal, i.e. no menses for at least 12 consecutive months, or is without a uterus).
  • Location of the selected SCCIS lesion:
  • within 5 cm of an incompletely healed wound
  • within 2 cm of an eye, nose, or ear
  • within 1 cm of a scar
  • on the scalp, digits, lips, hands, feet, or ano-genital region
Show all 55Show fewer
  • SCCIS lesions that have atypical clinical appearance, e.g. hypertrophic or hyperkeratotic or pigmented or ulcerated.
  • Histological evidence of nodular basal cell carcinoma (nBCC), superficial basal cell carcinoma (sBCC) or invasive squamous cell carcinoma (SCC) of the SCCIS in the biopsy sample.
  • Presence of suspected basal cell carcinoma (BCC) or invasive squamous cell carcinoma (SCC) within 2 cm of the selected SCCIS lesion.
  • Presence of known or suspected metastatic disease.
  • History or evidence of skin conditions other than SCCIS that would interfere with evaluation of the study medication (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)
  • of the selected SCCIS lesion at any time; or
  • within 2 cm of the selected SCCIS lesion during the 4 weeks prior to screening visit; or
  • anticipated treatment within 10 cm of the selected SCCIS lesion during the study.
  • Treatment with 5-fluorouracil, imiquimod, diclofenac, or masoprocol
  • of the selected SCCIS lesion at any time; or
  • within 2 cm of the selected SCCIS lesion during the 6 months prior to study entry; or
  • anywhere during the 4 weeks prior to study entry; or
  • anticipated treatment anywhere during the study.
  • Treatment with photodynamic therapy
  • of the selected SCCIS lesion at any time; or
  • within 10 cm of the selected SCCIS lesion during the 6 months prior to study entry; or
  • anticipated treatment within 10 cm of the selected SCCIS lesion during the study.
  • Treatment with ionising radiation
  • of the selected SCCIS lesion at any time; or
  • within 2 cm of the selected SCCIS lesion prior to study entry; or
  • anticipated treatment anywhere during the study.
  • Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathioprine, chlorambucil, nitrogen mustard, methotrexate), or interferon/interferon inducers (other than imiquimod)
  • within 4 weeks prior to study entry; or
  • anticipated treatment during the study.
  • Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids, such as α and β hydroxy acids and glycolic acids), topical retinoids, or light chemical peels
  • of the selected SCCIS lesion at any time; or
  • within 2 cm of the selected SCCIS lesion during the 4 weeks prior to study entry; or
  • anticipated treatment within 2 cm of the selected SCCIS lesion during the study.
  • Treatment with psoralen plus ultraviolet light A [UVA] (PUVA) or use of ultraviolet light B (UVB) therapy
  • of the selected SCCIS lesion at any time; or
  • anywhere during the 6 months prior to study entry; or
  • anticipated treatment anywhere during the study.
  • Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene)
  • 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 or topical steroids to the selected SCCIS lesion during the study.
  • SCCIS lesions requiring Mohs micrographic surgery.
  • Anticipated need for inpatient hospitalisation or inpatient surgery during the study.
  • Concurrent disease that suppresses the immune system (e.g. HIV, hepatitis) or uncontrolled systemic disease (e.g. uncontrolled hypertension, poorly controlled diabetes).
  • Use of medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab)
  • within 4 weeks prior to study entry; or
  • anticipated treatment during the study.
  • 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.
  • Entry into another investigational drug or device study while enrolled in this study.
  • 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.
  • Selected SCCIS lesion within 5 cm of an area previously treated with PEP005.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • The Skin Centre

    Benowa, Queensland, 4217

  • Siller Medical

    Brisbane, Queensland, 4000

  • Southderm Pty Ltd

    Kogarah, New South Wales, 2217

Other trials in Australia

About this study

Official title: Multi-centre, Open-label Study to Determine the Safety and Efficacy of PEP005 0.05% Topical Gel in Patients With Cutaneous Squamous Cell Carcinoma In Situ (SCCIS, Bowen's Disease)

The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease).

Read the detailed description

Squamous cell carcinomas (SCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and some topical pharmaceutical therapies, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of SCC 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, three well-controlled studies with PEP005 gel in humans have been completed. In the first and second completed studies, sixteen (1st study) and sixty-four (2nd study) patients received one or two applications of PEP005 0.0025% or 0.01% or 0.05% or vehicle gel to actinic keratoses. In the third completed study, sixty patients received two applications of PEP005 0.0025% or 0.01% or 0.05% or vehicle gel to superficial basal cell carcinomas. Results from all studies show good tolerance and evidence of activity.

The current study is designed to evaluate the efficacy and safety of two applications of 0.05% PEP005 gel in patients with SCCIS on the extremities, trunk or face. Approximately 24 patients are planned to be included from multiple Australian centers. 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 2-3 months.

Being tested
PEP005
Keywords
SCCIS, Bowens disease, PEP005, Topical, Dermatology, Cutaneous Squamous Cell Carcinoma in situ
Medical subject headings
Carcinoma, Squamous Cell, Bowen's Disease

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. Efficacy

Timeline

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

  1. First posted24 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2006
  4. Study completionDec 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329121
Sponsor's protocol ID
PEP005-008
Status last verified
Jan 2015
First submitted
22 May 2006
Last updated
19 Jan 2015
Results posted
No

Publications

  • Rosen R, Freeman M, Siller G, Zibert JR, Katsamas J, Knudsen KM, Spelman L. Ingenol mebutate 0.05% gel reduces cancer cells in squamous cell carcinoma in situ and shows marginal effect in seborrheic keratosis. JDDG J German Soc Dermatol 2013; 11(Suppl. 7): 22

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEP005 in people with Carcinoma, Squamous Cell, run by Peplin at 3 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 8 inclusion and 55 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 3 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 NCT00329121, which also lists 1 linked publication.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in