Actinic KeratosisNCT02209012
Twelve Month Follow-Up of CP0108
An observational study of Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study. 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?
- Aminolevulinic Acid (ALA) and BLU-U Blue Light Photodynamic Therapy Illuminator
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2014to Apr 2016
- 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: Subjects who were enrolled in the DUSA-CP0108 study, completed their assigned treatment (ALA-PDT or vehicle + blue-light) and Visit 6.
Who may be able to join
- Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
MOORE Clinical Research, Inc
Brandon, Florida, 33609
Shideler Clinical Research Center
Carmel, Indiana, 46032
J&S Studies, Inc
College Station, Texas, 77845
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
UCSD Dermatology
San Diego, California, 92122
Spencer Clinical Services
St. Petersburg, Florida, 33716
About this study
Official title: Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities)
The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.
- Conditions
- Actinic Keratosis
- Being tested
- Aminolevulinic Acid (ALA), Topical Solution Vehicle, BLU-U Blue Light Photodynamic Therapy Illuminator
- Keywords
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid (ALA)Drug
Also called Levulan Kerastick
Levulan PDT given in CP0108
Topical Solution VehicleDrug
Vehicle PDT given in CP0108
BLU-U Blue Light Photodynamic Therapy IlluminatorDevice
PDT given in CP0108
| Study group | Role | What they receive |
|---|---|---|
| ALA | Subjects who received ALA in CP0108 Receives: Drug: Aminolevulinic Acid (ALA); Device: BLU-U Blue Light Photodynamic Therapy Illuminator | |
| Vehicle | Subjects who received Vehicle in CP0108 Receives: Drug: Topical Solution Vehicle; Device: BLU-U Blue Light Photodynamic Therapy Illuminator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Recurrence Rate
percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up
Measured: Month 12
Duration of Response
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which a previously treated and cleared lesion recurs. If a subject begins or receives treatment for previously cleared AK lesions in the Treatment Area between scheduled visits, the date the treatment started will be the end of treatment response, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
Measured: one year
Lesion Recurrence Rate
the proportion of lesions that were CR at Week 12 in CP0108 that are visible or palpable at Visit 10, will be determined for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study.
Measured: Month 12
Duration of Lesion Response
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which the AK lesion recurs for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study. If a previously cleared lesion receives treatment between scheduled visits, the date the treatment started will be the end of treatment response for that lesion, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionApr 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Marcus, MD, PhD, Study director, DUSA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209012
- Sponsor's protocol ID
- CP0108A
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2014
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities)
- ClinicalTrials.gov ID
- NCT02209012
- Acronym / sponsor ID
- CP0108A
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Aug 2014 (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 purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA | – | Drug: Aminolevulinic Acid (ALA), Device: BLU-U Blue Light Photodynamic Therapy IlluminatorSubjects who received ALA in CP0108 |
| Vehicle | – | Drug: Topical Solution Vehicle, Device: BLU-U Blue Light Photodynamic Therapy IlluminatorSubjects who received Vehicle in CP0108 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who were enrolled in the DUSA-CP0108 study, completed their assigned treatment (ALA-PDT or vehicle + blue-light) and Visit 6.
Key inclusion criteria (1 listed)
- Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Aminolevulinic Acid (ALA)Also: Levulan KerastickLevulan PDT given in CP0108 | Drug | ALA |
| Topical Solution VehicleVehicle PDT given in CP0108 | Drug | Vehicle |
| BLU-U Blue Light Photodynamic Therapy IlluminatorPDT given in CP0108 | Device | ALA, Vehicle |
Primary outcome
Subject Recurrence Rate
Time frame: Month 12
percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up
Duration of Response
Time frame: one year
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which a previously treated and cleared lesion recurs. If a subject begins or receives treatment for previously cleared AK lesions in the Treatment Area between scheduled visits, the date the treatment started will be the end of treatment response, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
Lesion Recurrence Rate
Time frame: Month 12
the proportion of lesions that were CR at Week 12 in CP0108 that are visible or palpable at Visit 10, will be determined for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study.
Duration of Lesion Response
Time frame: one year
the time from Week 12 (in the DUSA-CP0108 study) to the visit at which the AK lesion recurs for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study. If a previously cleared lesion receives treatment between scheduled visits, the date the treatment started will be the end of treatment response for that lesion, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
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 23 Sep 2016.
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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.
Stuart Marcus, MD, PhD study director
DUSA Pharmaceuticals, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 13 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 1 inclusion and 0 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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?
Subject Recurrence Rate (time frame: Month 12). The study lists 4 primary outcomes in all. 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 23 Sep 2016.