Actinic KeratosisDaylightPDTNCT02867722
Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States
A study testing aminolevulinic acid HCl in people with Actinic Keratosis and Non-melanoma Skin Cancer, run by Brigham and Women's Hospital.
Trial summary
In this study, daylight PDT will be administered to interested patients at Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective and painless alternative to traditional PDT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis, Non-melanoma Skin Cancer
- What is being tested?
- aminolevulinic acid HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years referred for the treatment of 5 or more visible or palpable actinic keratoses on one treatment area
Who cannot join
- Age less than 18 years of age.
- Pregnant women.
- Non-English speaking patients.
- Treatment of actinic keratoses with other modalities including topical 5-fluorouracil, topical imiquimod, conventional PDT, alpha-hydroxy-acids, and glycolic acids within 2 months
- Use of retinoids within 1 month
- Use of the following medications: griseofulvin, thiazide diuretics, sulfonyureas, phenothiazines, sulfonamides, and tetracyclines
- History of cutaneous photosensitivity, lupus, porphyrias, or any other photosensitizing condition
About this study
In this study, daylight PDT will be administered to interested patients at Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective and painless alternative to traditional PDT. Daylight PDT involves application of the photosensitizer in the physician's office followed by exposure to daylight.
Read the detailed description
The principal investigator will inform patients about the study during their initial consultation at the Mohs and Dermatologic Surgery Center, Dana-Farber/Brigham and Women's Cancer Center at Faulkner Hospital. The patients will be encouraged to make further inquiries about the study if they are interested. Informed consent will be obtained prior to initiating the treatment. If patients are interested in taking part in the study, the investigator will approach them in private to review the consent form and address any study-related questions.
A clinical examination along with photographs will be performed prior to application of the photosensitizer to determine the baseline number of actinic keratoses. The treatment steps were adapted from the daylight-PDT protocol presented in the phase III European multicenter study.9 The treatment will be performed if the temperature conditions are suitable to stay outdoors for 2.5 hours and not under any rainy weather conditions; however, treatment can be performed on overcast days. Suitable weather conditions include an outdoor temperature greater than 50 and between the months of April and November. This is based on a minimum of 8 J cm-2 (although other studies have shown that only 3.5 J cm-2) protoporphyrin IX light dose. A study of various geographic regions found this minimum dose was present in Turin, Italy, which is a similar latitude to Boston, MA.10 Weather conditions will be recorded on the day of treatment and final analysis will be stratified by temperature and weather conditions to evaluate whether this has impacted treatment. Subjects will be advised of the treatment requirements at the time of appointment booking and will be instructed to call the morning of their appointment to confirm that treatment can proceed. Subjects will scrub their faces with warm soapy water to clean and descale the skin and any hypertrophic AKs will be curetted. A chemical sunscreen will be applied to all sun exposed areas followed by one applicator of ALA (Levulan, DUSA pharmaceuticals, Wilmington, MA) to each treatment area. Subjects will be instructed to be exposed to daylight within 30-60 minutes of application and will remain outside in the shade for two and a half hours. Subjects will then remove the ALA and will be instructed to minimize sun exposure and to apply a physical sunscreen (zinc oxide or titanium dioxide) and wear protective clothing for the next 48 hours. This protocol will be repeated after one month unless complete response is documented at the month follow up. Subjects with a history of HSV infection will receive prophylaxis valtrex 500mg daily for 3 days.
- Conditions
- Actinic Keratosis, Non-melanoma Skin Cancer
- Being tested
- aminolevulinic acid HCl
- 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 HClDrug
Also called Levulan
Drug will be administered to consented patients
| Study group | Role | What they receive |
|---|---|---|
| Daylight PDT | Experimental | Patients will receive daylight-PDT treatment (aminolevulinic acid) Receives: Drug: aminolevulinic acid HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reduction in the number of actinic keratoses after daylight PDT treatment
Measured: 1 year and 5 years
Secondary outcomes (3)
Number of non-melanoma skin cancers at 1- and 5-years compared to the number of skin
Measured: 1 year and 5 years
Number of patients with treatment related adverse events as assessed by CTCAE v4.0
Measured: 5 years
Measure patient satisfaction at 1- and 5- years using the Treatment Satisfaction Questionnaire for Medication
Measured: 1 year and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The PI decided to not proceed with the trial due to lack of funding.
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.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Stamell Ruiz, Brigham and Women's Hospital
- Investigators
- Emily Stamell Ruiz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867722
- Sponsor's protocol ID
- 2016P000913
- Acronym
- DaylightPDT
- Status last verified
- Jan 2021
- First submitted
- 18 Jul 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be aggregated and analyzed
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States
- ClinicalTrials.gov ID
- NCT02867722
- Acronym / sponsor ID
- DaylightPDT / 2016P000913
- Conditions
- Actinic Keratosis, Non-melanoma Skin Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI decided to not proceed with the trial due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Aug 2016 (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.
In this study, daylight PDT will be administered to interested patients at Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective and painless alternative to traditional PDT. Daylight PDT involves application of the photosensitizer in the physician's office followed by exposure to daylight.
Detailed description
The principal investigator will inform patients about the study during their initial consultation at the Mohs and Dermatologic Surgery Center, Dana-Farber/Brigham and Women's Cancer Center at Faulkner Hospital. The patients will be encouraged to make further inquiries about the study if they are interested. Informed consent will be obtained prior to initiating the treatment. If patients are interested in taking part in the study, the investigator will approach them in private to review the consent form and address any study-related questions.
A clinical examination along with photographs will be performed prior to application of the photosensitizer to determine the baseline number of actinic keratoses. The treatment steps were adapted from the daylight-PDT protocol presented in the phase III European multicenter study.9 The treatment will be performed if the temperature conditions are suitable to stay outdoors for 2.5 hours and not under any rainy weather conditions; however, treatment can be performed on overcast days. Suitable weather conditions include an outdoor temperature greater than 50 and between the months of April and November. This is based on a minimum of 8 J cm-2 (although other studies have shown that only 3.5 J cm-2) protoporphyrin IX light dose. A study of various geographic regions found this minimum dose was present in Turin, Italy, which is a similar latitude to Boston, MA.10 Weather conditions will be recorded on the day of treatment and final analysis will be stratified by temperature and weather conditions to evaluate whether this has impacted treatment. Subjects will be advised of the treatment requirements at the time of appointment booking and will be instructed to call the morning of their appointment to confirm that treatment can proceed. Subjects will scrub their faces with warm soapy water to clean and descale the skin and any hypertrophic AKs will be curetted. A chemical sunscreen will be applied to all sun exposed areas followed by one applicator of ALA (Levulan, DUSA pharmaceuticals, Wilmington, MA) to each treatment area. Subjects will be instructed to be exposed to daylight within 30-60 minutes of application and will remain outside in the shade for two and a half hours. Subjects will then remove the ALA and will be instructed to minimize sun exposure and to apply a physical sunscreen (zinc oxide or titanium dioxide) and wear protective clothing for the next 48 hours. This protocol will be repeated after one month unless complete response is documented at the month follow up. Subjects with a history of HSV infection will receive prophylaxis valtrex 500mg daily for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daylight PDT | Experimental | Drug: aminolevulinic acid HClPatients will receive daylight-PDT treatment (aminolevulinic acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years referred for the treatment of 5 or more visible or palpable actinic keratoses on one treatment area
Key exclusion criteria (7 listed)
- Age less than 18 years of age.
- Pregnant women.
- Non-English speaking patients.
- Treatment of actinic keratoses with other modalities including topical 5-fluorouracil, topical imiquimod, conventional PDT, alpha-hydroxy-acids, and glycolic acids within 2 months
- Use of retinoids within 1 month
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 HClAlso: LevulanDrug will be administered to consented patients | Drug | Daylight PDT |
Primary outcome
Number of patients with reduction in the number of actinic keratoses after daylight PDT treatment
Time frame: 1 year and 5 years
3 secondary outcomes
Number of non-melanoma skin cancers at 1- and 5-years compared to the number of skin
Time frame: 1 year and 5 years
Number of patients with treatment related adverse events as assessed by CTCAE v4.0
Time frame: 5 years
Measure patient satisfaction at 1- and 5- years using the Treatment Satisfaction Questionnaire for Medication
Time frame: 1 year and 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No. Data will be aggregated and analyzed
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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.
Emily Stamell Ruiz, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing aminolevulinic acid HCl in people with Actinic Keratosis and Non-melanoma Skin Cancer, run by Brigham and Women's Hospital.
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 7 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: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with reduction in the number of actinic keratoses after daylight PDT treatment (time frame: 1 year and 5 years). 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 1 Feb 2021.