Actinic KeratosisPhase 3NCT00916006
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
A Phase 3 study testing PEP005 Gel in people with Actinic Keratosis, run by Peplin at 21 sites in 2 countries.
Trial summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp. 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?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jun 2009to Sep 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
- Patient is male or female and at least 18 years of age
- Female patients must be of either:
- Non-childbearing potential, post-menopausal
- Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy
Who cannot join
- Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022
Glazer Dermatology
Buffalo Grove, Illinois, 60089
J & S Studies, Inc.
College Station, Texas, 77845
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Dermatology Research Associates
Los Angeles, California, 90045
University of Miami, Skin Research Camp
Miami, Florida, 33136
Dermatology Research Associates
Nashville, Tennessee, 37203
Medaphase Inc
Newnan, Georgia, 30263
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Dermatology Specialists Inc
Oceanside, California, 92056
Pedia Research LLC
Owensboro, Kentucky, 42301
Wake Research Associates
Raleigh, North Carolina, 27612
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Skin Surgery Medical Group Inc.
San Diego, California, 92117
Conant Medical Group
San Francisco, California, 94114
Dermatology Associates of Tyler
Tyler, Texas, 75703
Center for Clinical Studies
Webster, Texas, 77598
Australia2 sites
Southderm Pty Ltd
Kogarah, New South Wales, 2217
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, 2217
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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005 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 GelDrug
Also called PEP005
0.015%, three day treatment
Vehicle gelDrug
Also called Placebo
Vehicle gel, three day treatment
| Study group | Role | What they receive |
|---|---|---|
| PEP005 gel | Experimental | PEP005 gel, 0.015% applied once daily for three consecutive days Receives: Drug: PEP005 Gel |
| Vehicle gel | Placebo comparator | Vehicle gel applied once daily for three consecutive days Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Measured: 57 days
Secondary outcomes (1)
Patients With Partial Clearance of Actinic Keratosis (AK)
Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
Measured: baseline and 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 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.
- 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Bauer, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916006
- Sponsor's protocol ID
- PEP005-016
- Status last verified
- Mar 2015
- First submitted
- 4 Jun 2009
- Last updated
- 2 Apr 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 2 Apr 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
- ClinicalTrials.gov ID
- NCT00916006
- Acronym / sponsor ID
- PEP005-016
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, Actinic keratosis, PEP005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 21 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
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 gel | Experimental | Drug: PEP005 GelPEP005 gel, 0.015% applied once daily for three consecutive days |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelVehicle gel applied once daily for 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)
- Patient is male or female and at least 18 years of age
- Female patients must be of either:
Key exclusion criteria (3 listed)
- Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 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: PEP0050.015%, three day treatment | Drug | PEP005 gel |
| Vehicle gelAlso: PlaceboVehicle gel, three day treatment | Drug | Vehicle gel |
Primary outcome
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
Time frame: 57 days
Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
1 secondary outcome
Patients With Partial Clearance of Actinic Keratosis (AK)
Time frame: baseline and 57 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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.
- 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
21 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 21 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 2 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 21 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. 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 21 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?
Patients With Complete Clearance of Actinic Keratosis (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 NCT00916006, 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 2 Apr 2015; AzTrials last refreshed its copy on 28 Oct 2026.