Skin CancerPhase 1/2NCT03110159
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
A Phase 1/2 study testing Levulan® Kerastick® and BLU-U Blue Light Photodynamic Therapy in people with Skin Cancer and Non-melanoma Skin Cancer, run by Medical Dermatology Specialists at 1 site in United States.
Trial summary
This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin
- What is being tested?
- Levulan® Kerastick® and BLU-U Blue Light Photodynamic Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 20 Feb 2024
- Phase
- Phase 1/2
- 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
Who may be able to join
- Received solid organ transplant
- 3-24 months post-transplant (any number of transplant)
- Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.
- No prior history of NMSC in the treatment fields
- No AK/Bowen's disease in the treatment fields within the last 3 months.
- Moderate to severe sun damage
- Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication
Who cannot join
- Patients with Fitzpatrick's scale skin type IV-VI
- Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
- Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
- Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
- Unable to return for follow-up visits and tests
- Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Dermatology Specialists
Phoenix, Arizona, 85006
About this study
Official title: Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).
The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
- Being tested
- Levulan® Kerastick®, BLU-U Blue Light Photodynamic Therapy
- Keywords
- Photodynamic therapy, Prevention, Actinic Keratosis, Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Solid Organ Transplant, PDT
- Medical subject headings
- Skin Neoplasms, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levulan® Kerastick®Drug
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
BLU-U Blue Light Photodynamic TherapyDrug
Also called blue light illumination
3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Levulan® Kerastick® and blue light illumination | Experimental | Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds.
Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years. Receives: Drug: Levulan® Kerastick®; Drug: BLU-U Blue Light Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary prevention of AKs in recently transplanted solid organ recipient
Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.
Measured: 3 Years
Time to occurrence of AKs in recently transplanted solid organ recipient
Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.
Measured: 3 Years
Primary prevention of NMSC in recently transplanted solid organ recipient
Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.
Measured: 3 Years
Time to occurrence of NMSC in recently transplanted solid organ recipient
Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.
Measured: 3 Years
Secondary outcomes (2)
Pain control with Levulan-PDT in Solid Organ Transplant Recipient
Pain will be assessed on the 10 point Visual Analogue Scale (VAS), as mild (0-3), moderate (4-7) or severe (8-10). Patients will be asked to rate the pain at the beginning, midway point (approximately 8 minutes later), and at the end of each PDT session.
Measured: Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
The number of participants with treatment related adverse events as assessed by the CTCAE v4.0
The number of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start29 Aug 2017
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Dermatology Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Nathalie C. Zeitouni, MD, Principal investigator, Medical Dermatology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110159
- Sponsor's protocol ID
- PHXB-16-0142-80-15
- Other IDs
- MDS
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03110159
- Acronym / sponsor ID
- PHXB-16-0142-80-15
- Keywords
- Photodynamic therapy, Prevention, Actinic Keratosis, Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Solid Organ Transplant, PDT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical Dermatology SpecialistsUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).
The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levulan® Kerastick® and blue light illumination | Experimental | Drug: Levulan® Kerastick®, Drug: BLU-U Blue Light Photodynamic TherapyLevulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds. Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Received solid organ transplant
- 3-24 months post-transplant (any number of transplant)
- Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.
- No prior history of NMSC in the treatment fields
- No AK/Bowen's disease in the treatment fields within the last 3 months.
Key exclusion criteria (6 listed)
- Patients with Fitzpatrick's scale skin type IV-VI
- Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
- Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
- Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
- Unable to return for follow-up visits and tests
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 |
|---|---|---|
| Levulan® Kerastick®Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light | Drug | Levulan® Kerastick® and blue light illumination |
| BLU-U Blue Light Photodynamic TherapyAlso: blue light illumination3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds. | Drug | Levulan® Kerastick® and blue light illumination |
Primary outcome
Primary prevention of AKs in recently transplanted solid organ recipient
Time frame: 3 Years
Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.
Time to occurrence of AKs in recently transplanted solid organ recipient
Time frame: 3 Years
Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.
Primary prevention of NMSC in recently transplanted solid organ recipient
Time frame: 3 Years
Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.
Time to occurrence of NMSC in recently transplanted solid organ recipient
Time frame: 3 Years
Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.
2 secondary outcomes
Pain control with Levulan-PDT in Solid Organ Transplant Recipient
Time frame: Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
The number of participants with treatment related adverse events as assessed by the CTCAE v4.0
Time frame: 3 Years
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 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Nathalie C. Zeitouni, MD principal investigator
Medical Dermatology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Levulan® Kerastick® and BLU-U Blue Light Photodynamic Therapy in people with Skin Cancer and Non-melanoma Skin Cancer, run by Medical Dermatology Specialists at 1 site 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 7 inclusion and 6 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary prevention of AKs in recently transplanted solid organ recipient (time frame: 3 Years). 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 15 Mar 2024.