An interventional study of Levulan and Red Light PDT in Basal Cell Nevus Syndrome, sponsored by Edward Maytin, MD, PhD. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Edward Maytin, MD, PhD · Not applicable, Interventional, and Treatment
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Among 20 studies in Basal Cell Nevus Syndrome with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Basal Cell Nevus Syndrome · United States.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, this one is the 18th largest by enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2016, is one of 2 with no phase, and was the 10th registered.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
Browse Basal Cell Nevus Syndrome studies →1 of the 20 studies in Basal Cell Nevus Syndrome with a site in United States is open now. Recruiting first, the newest first:
St. Jude Children's Research Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 3 Basal Cell Nevus Syndrome studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 3
First in 2004; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Median enrollment 35 across the 18 interventional studies, 765 across the 2 observational. Of the 18 that completed or were terminated, 12 (67%) have results posted.
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8 of 20 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Edward Maytin, MD, PhD as lead sponsor.
Edward Maytin, MD, PhD has 1 study filed under Basal Cell Nevus Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Basal Cell Nevus Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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Major criteria are:
Minor criteria are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
Drug: Levulan · Other: Red Light PDT · Other: Blue Light PDT
Levulan application followed by Red or Blue light PDT
Also known as: Levulan™, Levulan® Kerastick® for Topical Solution, 5-aminolevulinic acid, aminolevulinic acid HCL, ALA
Aktilite™ (red lamp) after Levulan application on lesions
Also known as: Aktilite™, Red Lamp, Red Light, PDT
Blu-U® (blue lamp) after Levulan application on lesions
Also known as: Blu-U, Blue Lamp, Blue Light, PDT
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).
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
| Milestone | Red Light/Blue Light Participants |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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).
| Percentage of tumors cleared | Red Light Photodynamic Therapy | Blue Light Photodynamic Therapy |
|---|---|---|
| Tumor Clearance Rate Following Red or Blue Light PDT | 87.3 (75 to 96) | 99 (97 to 100) |
Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
| VAS score value | Pain During Red Light | Pain During Blue Light |
|---|---|---|
| Pain During Illumination | 5.6 ± 2.0 | 3.7 ± 1.7 |
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.
| Scores on the rating scale | Red Light Treatment | Blue Light Treatment |
|---|---|---|
| Patient Satisfaction Survey | 5.3 (5 to 6) | 5.6 (5 to 6) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Red Light Photodynamic Therapy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Blue Light Photodynamic Therapy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Red Light / Blue Light Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | Red Light / Blue Light Participants |
|---|---|
| Mean | 42 (33 to 54) |
| Sex: Female, Male(Participants) | Red Light / Blue Light Participants |
|---|---|
| Female | 1 |
| Male | 2 |
| Region of Enrollment(Participants) | Red Light / Blue Light Participants |
|---|---|
| United States | 3 |
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2016 to primary completion in Sep 2016, 7 months.
Results were first posted in Jun 2017, 9 months after primary completion.
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aminolevulinic Acid