Superficial Basal Cell CarcinomaPhase 2NCT01325688
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities
A Phase 2 study testing PEP005 (ingenol mebutate) Gel, 0.05%, Aluminium disk and OpSite(TM) disk in people with Superficial Basal Cell Carcinoma, run by Peplin at 7 sites in Australia.
Trial summary
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- PEP005 (ingenol mebutate) Gel, 0.05%, Aluminium disk and OpSite(TM) disk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesAustralia
- Study dates
- Apr 2011to Mar 2012
- 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
- Must be male or female and at least 18 years of age
- Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
- Ability to provide informed consent
- primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision
Who cannot join
- location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
- Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
- Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
- Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
- Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
- Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit.
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- Use of systemic retinoids.
- Those who are currently participating in any other clinical trial
- Those known or suspected of not being able to comply with the requirements of the protocol
- Females who are pregnant or are breastfeeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
The Skin Centre
Benowa, Queensland, 4217
Southderm Pty Ltd
Kogarah, New South Wales, 2217
St George Dermatology
Kogarah, New South Wales, 2217
Dermatology Institute of Victoria
South Yarra, Victoria, 3141
St John of God Dermatology
Subiaco, Western Australia, 6008
Burswood Dermatology
Victoria Park, Western Australia, 6100
Specialist Connect
Woolloongabba, Queensland, 4102
About this study
Official title: A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- PEP005 (ingenol mebutate) Gel, 0.05%, Aluminium disk, OpSite(TM) disk
- Keywords
- PEP005, Peplin, sBCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 (ingenol mebutate) Gel, 0.05%Drug
PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days
Aluminium diskDevice
OpSite(TM) diskDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days Receives: Drug: PEP005 (ingenol mebutate) Gel, 0.05%; Device: Aluminium disk |
| Group 2 | Experimental | PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days Receives: Drug: PEP005 (ingenol mebutate) Gel, 0.05%; Device: OpSite(TM) disk |
| Group 3 | Experimental | PEP005 0.05% applied with no occlusion for up to three consecutive days Receives: Drug: PEP005 (ingenol mebutate) Gel, 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
Measured: 120 days
Secondary outcomes (1)
Histological and clinical clearance of sBCC lesions.
Number of participants with histological and clinical clearance of sBCC lesions.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Morley, Study director, Peplin Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325688
- Sponsor's protocol ID
- PEP005-037
- Status last verified
- Jan 2016
- First submitted
- 25 Mar 2011
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities
- ClinicalTrials.gov ID
- NCT01325688
- Acronym / sponsor ID
- PEP005-037
- Conditions
- Superficial Basal Cell Carcinoma
- Keywords
- PEP005, Peplin, sBCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: PEP005 (ingenol mebutate) Gel, 0.05%, Device: Aluminium diskPEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days |
| Group 2 | Experimental | Drug: PEP005 (ingenol mebutate) Gel, 0.05%, Device: OpSite(TM) diskPEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days |
| Group 3 | Experimental | Drug: PEP005 (ingenol mebutate) Gel, 0.05%PEP005 0.05% applied with no occlusion for up to three consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be male or female and at least 18 years of age
- Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
- Ability to provide informed consent
- primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision
Key exclusion criteria (10 listed)
- location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
- Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
- Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
- Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
- Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP005 (ingenol mebutate) Gel, 0.05%PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days | Drug | Group 1, Group 2, Group 3 |
| Aluminium disk | Device | Group 1 |
| OpSite(TM) disk | Device | Group 2 |
Primary outcome
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
Time frame: 120 days
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
1 secondary outcome
Histological and clinical clearance of sBCC lesions.
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Therapeutic Goods AdministrationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Morley study director
Peplin Operations
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP005 (ingenol mebutate) Gel, 0.05%, Aluminium disk and OpSite(TM) disk in people with Superficial Basal Cell Carcinoma, run by Peplin at 7 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 4 inclusion and 10 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2016.