Actinic KeratosesPhase 3NCT00942604
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
A Phase 3 study testing PEP005 (ingenol mebutate) Gel in people with Actinic Keratoses, run by Peplin at 17 sites in United States.
Trial summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- PEP005 (ingenol mebutate) Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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;
- Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
- 4 to 8 AK lesions on non-head locations.
Who cannot join
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or 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 treatment area
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.
Austin, Texas, 78759
Glazer Dermatology
Buffalo Grove, Illinois, 60089
Group Health Associates
Cincinnati, Ohio, 45220
Deaconess Clinic Downtown
Evansville, Indiana, 47713
Karl G. Heine Dermatology
Henderson, Nevada, 89002
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
The Education and Research Foundation
Lynchburg, Virginia, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Skin Specialists, PC
Omaha, Nebraska, 68144
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Skin Surgery Medical Group Inc.
San Diego, California, 92117
Dermatology Associates of Tyler
Tyler, Texas, 75703
About this study
Official title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
- Conditions
- Actinic Keratoses
- Being tested
- PEP005 (ingenol mebutate) Gel, Vehicle 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 (ingenol mebutate) GelDrug
two day treatment
Vehicle gelDrug
two day treatment
| Study group | Role | What they receive |
|---|---|---|
| PEP005 (ingenol mebutate) Gel | Active comparator | PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days Receives: Drug: PEP005 (ingenol mebutate) Gel |
| Vehicle gel | Placebo comparator | Vehicle gel once daily for 2 consecutive days Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Measured: 57 days
Secondary outcomes (1)
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
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 posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942604
- Sponsor's protocol ID
- PEP005-028
- Status last verified
- Nov 2013
- First submitted
- 19 Jul 2009
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
PubMed 22417254
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)
- ClinicalTrials.gov ID
- NCT00942604
- Acronym / sponsor ID
- PEP005-028
- Conditions
- Actinic Keratoses
- Keywords
- Peplin, Actinic keratosis, PEP005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Posted 19 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP005 (ingenol mebutate) Gel | Active comparator | Drug: PEP005 (ingenol mebutate) GelPEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelVehicle gel 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 (5 listed)
- Must be male or female and at least 18 years of age.
- Female patients must be of:
- Non-childbearing potential;
- Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
- 4 to 8 AK lesions on non-head locations.
Key exclusion criteria (3 listed)
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or 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 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 (ingenol mebutate) Geltwo day treatment | Drug | PEP005 (ingenol mebutate) Gel |
| Vehicle geltwo day treatment | Drug | Vehicle gel |
Primary outcome
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Time frame: 57 days
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
1 secondary outcome
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Time frame: 57 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22417254Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
- Food and Drug AuthorityLink 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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEP005 (ingenol mebutate) Gel in people with Actinic Keratoses, run by Peplin at 17 sites in United States.
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 5 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions (time frame: 57 days). 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 NCT00942604, 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 6 Mar 2015.