Actinic KeratosisPhase 3NCT00917306
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
A Phase 3 study testing PEP005 Gel in people with Actinic Keratosis, run by Peplin at 11 sites in 2 countries.
Trial summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- PEP005 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jun 2009to Sep 2009
- Phase
- Phase 3
- 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
- Patient is male or female and at least 18 years of age.
- Female patient must be of either:
- Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
- Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy
Who cannot join
- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Michigan Center for Research Corp
Clinton Twp, Michigan, 48038
Henry Ford Health Systems
Detroit, Michigan, 48202
Dermatology Research Associates
Nashville, Tennessee, 37203
Medaphase Inc
Newnan, Georgia, 30263
Park Avenue Dermatology
Orange Park, Florida, 32073
Oregon Health and Science University
Portland, Oregon, 97239-4501
Dermatology Associates of Rochester
Rochester, New York, 14623
Gwinnett Clinical Research Centre
Snellville, Georgia, 30078-3250
Australia3 sites
Dematology on Ward
Adelaide, South Australia, 5006
Dermatology Institute of Victoria
Melbourne, Victoria, 3141
St John of God Dermatology
Subiaco, Western Australia, 6008
About this study
Official title: A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005 Gel
- Keywords
- Peplin, Actinic keratosis, PEP005
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 GelDrug
Also called PEP005
0.05% two day treatment
| Study group | Role | What they receive |
|---|---|---|
| PEP005 gel | Experimental | PEP005 gel, 0.05% administered once daily for 2 consecutive days Receives: Drug: PEP005 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Measured: 57 days
Secondary outcomes (1)
Efficacy (complete and partial clearance of AK lesions)
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Eugene Bauer, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917306
- Sponsor's protocol ID
- PEP005-020
- Status last verified
- Mar 2015
- First submitted
- 8 Jun 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
- ClinicalTrials.gov ID
- NCT00917306
- Acronym / sponsor ID
- PEP005-020
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, Actinic keratosis, PEP005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Jun 2009 (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.
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP005 gel | Experimental | Drug: PEP005 GelPEP005 gel, 0.05% administered once daily for 2 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)
- Patient is male or female and at least 18 years of age.
- Female patient must be of either:
Key exclusion criteria (3 listed)
- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.
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 GelAlso: PEP0050.05% two day treatment | Drug | PEP005 gel |
Primary outcome
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Time frame: 57 days
1 secondary outcome
Efficacy (complete and partial clearance of AK lesions)
Time frame: 57 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 15 Apr 2015.
- Food and Drug AuthorityLink provided by the sponsor.
- 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.
Eugene Bauer, MD study director
Chief Medical Officer
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEP005 Gel in people with Actinic Keratosis, run by Peplin at 11 sites in 2 countries.
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 3 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) (time frame: 57 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 15 Apr 2015.