Actinic KeratosisPhase 3NCT00915551
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 (Ingenol Mebutate) gel, 0.015% 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 (Ingenol Mebutate) gel, 0.015%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 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
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.
Austin, Texas, 78759
Laser Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Deaconess Clinic, Inc
Evansville, Indiana, 47713
Center for Dermatology
Fremont, California, 94538
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
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
The Education and Research Foundation
Lynchburg, Virginia, 24501
Mount Sinai School of Medicine
New York, New York, 10029-6574
Skin Specialists, PC
Omaha, Nebraska
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Dermatology Associates of Rochester, PC
Rochester, New York, 14623
Progressive Clinical Research
San Antonio, Texas, 78229
Premier Clinical Research
Spokane, Washington, 99204
Australia2 sites
The Skin Centre
Benowa, Queensland, 4217
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, 4152
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-IIb)
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 (Ingenol Mebutate) gel, 0.015%, 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) gel, 0.015%Drug
once daily for 3 consecutive days
Vehicle GelDrug
once daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| PEP005 (Ingenol Mebutate) gel | Experimental | Not described Receives: Drug: PEP005 (Ingenol Mebutate) gel, 0.015% |
| Vehicle gel | Placebo comparator | Not described Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance of Actinic Keratoses (AK) Lesions
Complete clearance of the treatment field
Measured: baseline and 57 days
Secondary outcomes (1)
Partial Clearance of Actinic Keratoses (AK)
Partial clearance defined as ≥ 75% reduction in the number of 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915551
- Sponsor's protocol ID
- PEP005-025
- Status last verified
- Nov 2013
- First submitted
- 4 Jun 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)
- ClinicalTrials.gov ID
- NCT00915551
- Acronym / sponsor ID
- PEP005-025
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, Actinic keratosis, PEP005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 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 16 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 (Ingenol Mebutate) gel | Experimental | Drug: PEP005 (Ingenol Mebutate) gel, 0.015% |
| Vehicle gel | Placebo comparator | Drug: Vehicle Gel |
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 (Ingenol Mebutate) gel, 0.015%once daily for 3 consecutive days | Drug | PEP005 (Ingenol Mebutate) gel |
| Vehicle Gelonce daily for 3 consecutive days | Drug | Vehicle gel |
Primary outcome
Complete Clearance of Actinic Keratoses (AK) Lesions
Time frame: baseline and 57 days
Complete clearance of the treatment field
1 secondary outcome
Partial Clearance of Actinic Keratoses (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 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.
- Therapeutic Goods AdministrationLink provided by the sponsor.
Related trials for Actinic Keratosis
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
Not yet recruiting
Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
Nonmelanoma Skin Cancer, Actinic Keratosis
Not yet recruitingPhase 1
5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
Actinic Keratoses
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
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.
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 (Ingenol Mebutate) gel, 0.015% 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 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 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 16 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?
Complete Clearance of Actinic Keratoses (AK) Lesions (time frame: baseline and 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 NCT00915551, 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; AzTrials last refreshed its copy on 30 Oct 2026.