Actinic KeratosisNCT00953732
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
An observational study of Actinic Keratosis, run by Peplin at 42 sites in 2 countries.
Trial summary
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area. 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?
- Lesion count
- How many people
- 117 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Aug 2009to Oct 2010
- Phase
- Observational
- 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
Study population: All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.
Who may be able to join
- Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
- Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
Who cannot join
- Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
- Early termination from study PEP005-016 or PEP005-025
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States38 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
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
Laser Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
J & S Studies, Inc.
College Station, Texas, 77845
Deaconess Clinic, Inc
Evansville, Indiana, 47713
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Center for Dermatology
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Karl G. Heine Dermatology
Henderson, Nevada, 89002
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, 77056
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, 46256
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
Dermatology Research Associates
Los Angeles, California, 90045
The Education and Research Foundation
Lynchburg, Virginia, 24501
University of Miami, Skin Research Camp
Miami, Florida, 33136
Dermatology Research Associates
Nashville, Tennessee, 37203
Mount Sinai School of Medicine
New York, New York, 10029-6574
Medaphase Inc
Newnan, Georgia, 30263
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507
Dermatology Specialists Inc
Oceanside, California, 92056
Skin Specialists, PC
Omaha, Nebraska, 68144
Pedia Research LLC
Owensboro, Kentucky, 42301
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Medical Research
Portland, Oregon, 97223
Wake Research Associates
Raleigh, North Carolina, 27612
Dermatology Associates of Rochester, PC
Rochester, New York, 14623
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Progressive Clinical Research
San Antonio, Texas, 78229
Skin Surgery Medical Group Inc.
San Diego, California, 92117
Conant Medical Group
San Francisco, California, 94114
Premier Clinical Research
Spokane, Washington, 99204
Dermatology Associates of Tyler
Tyler, Texas, 75703
Center for Clinical Studies
Webster, Texas, 77598
Australia4 sites
The Skin Centre
Benowa, Queensland, 4217
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, 4152
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 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
Read the detailed description
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
- Conditions
- Actinic Keratosis
- Being tested
- Lesion count
- 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.
Lesion countDrug
Also called AK lesion recurrence
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Lesion count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summarize treatment area recurrence of AK lesions, in the selected treatment area
Measured: 12 months
Secondary outcomes (1)
Summarize long-term safety data(incidence of AEs in the treatment area)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 117 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
- NCT00953732
- Sponsor's protocol ID
- PEP005-030
- Status last verified
- Mar 2015
- First submitted
- 4 Aug 2009
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.
PubMed 23553119
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
- ClinicalTrials.gov ID
- NCT00953732
- Acronym / sponsor ID
- PEP005-030
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, Actinic keratosis, PEP005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Aug 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.
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
Detailed description
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Lesion count |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.
Key inclusion criteria (2 listed)
- Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
- Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
Key exclusion criteria (2 listed)
- Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
- Early termination from study PEP005-016 or PEP005-025
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 |
|---|---|---|
| Lesion countAlso: AK lesion recurrenceLesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study. | Drug | 1 |
Primary outcome
Summarize treatment area recurrence of AK lesions, in the selected treatment area
Time frame: 12 months
1 secondary outcome
Summarize long-term safety data(incidence of AEs in the treatment area)
Time frame: 12 months
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 Mar 2015.
- Derived from this study: PubMed 23553119Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.
- 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
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by Peplin at 42 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 2 inclusion and 2 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 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 42 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.
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?
Summarize treatment area recurrence of AK lesions, in the selected treatment area (time frame: 12 months). 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 NCT00953732, 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 26 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.