Basal Cell Nevus SyndromeNCT02157623
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
A study testing Levulan, Red Light PDT and Blue Light PDT in people with Basal Cell Nevus Syndrome, run by Edward Maytin, MD, PhD at 1 site in United States.
Trial summary
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Nevus Syndrome
- What is being tested?
- Levulan, Red Light PDT and Blue Light PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 Dec 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men, women, and children of any age or ethnic group who meet eligibility
- Patients under 18 years of age must be accompanied and co-consented, by a parent or legal guardian.
- Patients must have a diagnosis of Basal Cell Nevus Syndrome (BCNS)
- For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a PTCH1 gene mutation
- Major criteria are:
- (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type
Show all 21Show fewer
- (2) keratocyst of the jaw prior to age 20
- (3) palmar or plantar pitting
- (4) lamellar calcification of the falx cerebri
- (5) medulloblastoma
- (6) first degree relative with BCNS
- Minor criteria are:
- (1) rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals
- (2) macrocephaly
- (3) cleft/lip or palate;
- (4) fibroma of the heart or ovary
- (5) ocular abnormalities
- (6) other rare abnormalities
- At least two BCC tumors, preferably more, located in different body regions or located greater than 10 cm apart in locations that can be reproducibly separated into red and blue illumination fields
- Female subjects are not pregnant or nursing or planning to become pregnant during the study
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Pregnant, planning on getting pregnant or nursing
- Currently participating in another clinical trial
- Using any topical treatment for their BCC tumors, unless discontinued at least 1 month prior
- Currently being treated for other cancers with medical or radiation therapy
- Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
- Patients with a history of a photosensitivity disease, including porphyria cutanea tarda
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.
Read the detailed description
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).
Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.
- Conditions
- Basal Cell Nevus Syndrome
- Being tested
- Levulan, Red Light PDT, Blue Light PDT
- Keywords
- Basal Cell Nevus Syndrome, Gorlin's Syndrome
- Medical subject headings
- Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevulanDrug
Also called Levulan™, Levulan® Kerastick® for Topical Solution, 5-aminolevulinic acid, aminolevulinic acid HCL
Levulan application followed by Red or Blue light PDT
Red Light PDTOther
Also called Aktilite™, Red Lamp, Red Light, PDT
Aktilite™ (red lamp) after Levulan application on lesions
Blue Light PDTOther
Also called Blu-U, Blue Lamp, Blue Light, PDT
Blu-U® (blue lamp) after Levulan application on lesions
| Study group | Role | What they receive |
|---|---|---|
| Red Light PDT and Blue Light PDT | Experimental | The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT. Receives: Drug: Levulan; Other: Red Light PDT; Other: Blue Light PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Clearance Rate Following Red or Blue Light PDT
The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).
Measured: 6 months
Secondary outcomes (2)
Pain During Illumination
Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
Measured: Maximum value reported during the illumination period
Patient Satisfaction Survey
Overall patient satisfaction with the technique will be assessed using a simple survey:
6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start1 Feb 2016
- Primary completion1 Sep 2016
- Study completion1 Dec 2016
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.
- Other trials for Basal Cell Nevus SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients received a different treatment to each half of their body. First Levulan with red light PDT (to tumors on one side of the body), and then Levulan with blue light PDT (to tumors on the other side of the body), at six treatment visits.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Maytin, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Edward Maytin, MD, PhD, The Cleveland Clinic
- Investigators
- Edward V. Maytin, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157623
- Sponsor's protocol ID
- CASE 2614
- Status last verified
- Jul 2020
- First submitted
- 2 Jun 2014
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
- ClinicalTrials.gov ID
- NCT02157623
- Acronym / sponsor ID
- CASE 2614
- Conditions
- Basal Cell Nevus Syndrome
- Keywords
- Basal Cell Nevus Syndrome, Gorlin's Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Edward Maytin, MD, PhDUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 2 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.
Detailed description
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).
Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients received a different treatment to each half of their body. First Levulan with red light PDT (to tumors on one side of the body), and then Levulan with blue light PDT (to tumors on the other side of the body), at six treatment visits.
| Arm | Type | Receives |
|---|---|---|
| Red Light PDT and Blue Light PDT | Experimental | Drug: Levulan, Other: Red Light PDT, Other: Blue Light PDTThe tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Men, women, and children of any age or ethnic group who meet eligibility
- Patients under 18 years of age must be accompanied and co-consented, by a parent or legal guardian.
- Patients must have a diagnosis of Basal Cell Nevus Syndrome (BCNS)
- For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a PTCH1 gene mutation
- Major criteria are:
Key exclusion criteria (6 listed)
- Pregnant, planning on getting pregnant or nursing
- Currently participating in another clinical trial
- Using any topical treatment for their BCC tumors, unless discontinued at least 1 month prior
- Currently being treated for other cancers with medical or radiation therapy
- Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
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 |
|---|---|---|
| LevulanAlso: Levulan™, Levulan® Kerastick® for Topical Solution, 5-aminolevulinic acid, aminolevulinic acid HCLLevulan application followed by Red or Blue light PDT | Drug | Red Light PDT and Blue Light PDT |
| Red Light PDTAlso: Aktilite™, Red Lamp, Red Light, PDTAktilite™ (red lamp) after Levulan application on lesions | Other | Red Light PDT and Blue Light PDT |
| Blue Light PDTAlso: Blu-U, Blue Lamp, Blue Light, PDTBlu-U® (blue lamp) after Levulan application on lesions | Other | Red Light PDT and Blue Light PDT |
Primary outcome
Tumor Clearance Rate Following Red or Blue Light PDT
Time frame: 6 months
The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).
2 secondary outcomes
Pain During Illumination
Time frame: Maximum value reported during the illumination period
Patient Satisfaction Survey
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Edward V. Maytin, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levulan, Red Light PDT and Blue Light PDT in people with Basal Cell Nevus Syndrome, run by Edward Maytin, MD, PhD 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 21 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 30 Jul 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2017). 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?
Tumor Clearance Rate Following Red or Blue Light PDT (time frame: 6 months). 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 30 Jul 2020.