Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study
Bibliographic record
Abstract
BACKGROUND: Actinic keratosis (AK) is characterized by preinvasive, cancerous lesions on sun-exposed skin that negatively affect patient quality of life and may progress to invasive squamous cell carcinoma (SCC). If untreated, AK may either regress or progress to SCC, with significant morbidity and possible lethal outcomes. The most commonly used treatments for AK are cryotherapy, topical chemotherapy and, more recently, photodynamic therapy (PDT). This clinical study is part of a project that aims to create specific light-emitting fabrics (LEFs) that strongly improve the efficiency and reliability of PDT as a treatment for AK. OBJECTIVE: This study aims to compare the efficacy and tolerability of a new PDT protocol involving the Flexitheralight device (N-PDT) with the classical protocol involving the Aktilite CL 128 device (C-PDT; Galderma Laboratories) for the treatment of AK. All participants receive both protocols. The primary objective of this study is to compare the lesion response rate after 3 months of N-PDT with C-PDT. Secondary objectives are evaluations of pain and local tolerance during treatment, clinical evolution of the subject's skin, and evaluations of patient quality of life and satisfaction. METHODS: The study is a split-face, intraindividual comparison of two PDT protocols. The total number of patients recruited was 42. Patients were exposed to a continuous red light with the Aktilite CL 128 device on one side of the face and to fractionated red illumination with the new device, Flexitheralight, on the other side of the face. Males or females over the age of 18 years with a clinical diagnosis of at least 10 previously untreated, nonpigmented, nonhyperkeratotic grade I and II AK lesions of the forehead and/or scalp were included and were recruited from the Department of Dermatology of the Centre Hospitalier Universitaire de Lille. The patients came to the investigational center for one treatment session (day 1), and they were followed up after 7 days, 3 months and 6 months. A second treatment session was performed on day 111 in cases in which an incomplete response was observed at the 3-month follow-up. Data will be analyzed using SAS software version 9.4 (SAS Institute Inc). Continuous variables will be reported as means and standard deviations, and categorical variables will be reported as frequencies and percentages. The Shapiro-Wilk test will be used to assess the normality of the distribution. RESULTS: The clinical investigation was performed by July 2018. Data analysis was performed at the end of 2018, and results are expected to be published in early 2019. CONCLUSIONS: This phase II clinical trial aims to evaluate the noninferior efficacy and superior tolerability of N-PDT compared to that of C-PDT. If N-PDT is both efficacious and tolerable, N-PDT could become the treatment of choice for AK due to its ease of implementation in hospitals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03076918; https://clinicaltrials.gov/ct2/show/NCT03076918 (archived by WebCite at http://www.webcitation.org/771KA0SSK). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11530.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".