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Non-Inferiority of Flexitheralight Protocol for Actinic Keratosis Treatment

This randomized, controlled phase II clinical study evaluates the non-inferiority of a new photodynamic therapy protocol involving a light-emitting, fabric-based device compared to the conventional protocol in treating actinic keratosis. Results show that the Flexitheralight protocol is equally effective, less painful, and can be performed in all weather conditions.

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Non-Inferiority of Flexitheralight Protocol for Actinic Keratosis Treatment

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  1. Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the non-inferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp. C. Vicentini1, 2, AS. Vignion-Dewalle1, E. Thecua1, F. Lecomte1, C. Maire1, 2, P. Deleporte1, H. Béhal3, D. Kerob4, A. Duhamel3, S. Mordon1, L. Mortier1, 2 1Univ. Lille, INSERM, CHU Lille, U1189 – ONCO-THAI, Lille, France 2Department of Dermatology, CHU Lille, Lille, France 3Univ. Lille, CHU Lille, EA 2694, Lille, France 4Galderma International SAS, La Défense, France British Journal of Dermatology. DOI: 10.111/bjd.17350

  2. AS. Vignion-Dewalle, Research engineer

  3. Introduction What’s already known? • Methyl aminolevulinate (MAL) photodynamic therapy (PDT) is an effective and non-invasive treatment for actinic keratosis (AK). • Treatment-associated pain is frequently experienced by patients treated with the conventional protocol (C-PDT). • PDT using daylight (D-PDT) as the activating light source has been confirmed as equally effective and less painful than C-PDT, but it cannot be performed in all weather conditions.

  4. Objective • Primary objective: To assess the non-inferiority, in terms of efficacy at three months, of a new PDT protocol applying irradiation with a light-emitting, fabric-based device (FLEXI-PDT) compared to C-PDT for treating AK. • Key secondary objective: To compare pain scores between FLEXI-PDT and C-PDT. • Other secondary objectives: • To evaluate the adverse effects at seven days • To evaluate the lesion complete response rate at six months • To evaluate the cosmetic outcome at three and six months • To evaluate the patient satisfaction

  5. Methods • Study design: Monocentric, randomized, controlled, non-inferiority clinical study. • Study population: Patients with two treatment areas with a similar number and grade of AK lesions (from 5 to 7 lesions), randomized to receive either FLEXI-PDT or C-PDT. • Treatment regimen:

  6. Methods • Treatment course:

  7. Primary objective If the lower limit of the 95% confidence interval (CI) of the absolute difference in lesion complete response rates at three months between FLEXI-PDT and C-PDT was less than the absolute margin of non-inferiority stated to -10%, FLEXI-PDT was declared non-inferior to C-PDT Methods • Evaluation course / endpoints: • Day 1: • Pain scores at the end of irradiation (from 0: no pain to 10: worst pain) • Day 7: • Adverse effects • Month 3: • Lesion complete response (complete vs. incomplete response) • Cosmetic outcome (“excellent”, “good”, “fair”, or “poor”) • Month 6: • Lesion complete response (complete vs. incomplete response) • Cosmetic outcome (“excellent”, “good”, “fair”, or “poor”)

  8. Results • Efficacy: • The lower limit of the 95% CI was higher than -10% → The non-inferiority at three months of FLEXI-PDT compared to C-PDT was supported (primary objective) • The same finding was obtained at six months

  9. Results • Pain: • Pain scores significantly lower for FLEXI-PDT compared to C-PDT → The superiority in tolerability of FLEXI-PDT compared to C-PDT was supported (key secondary objective) • Pain scores close to zero for FLEXI-PDT→ FLEXI-PDT is nearly pain-free

  10. Results • Others secondary objectives: • Similar local side effects for FLEXI-PDT and C-PDT • Similar cosmetic outcomes between FLEXI-PDT and C-PDT • Higher patient satisfaction and preference for FLEXI-PDT compared to C-PDT

  11. Discussion • This study found: • The significant non-inferiority in efficacy of FLEXI-PDT compared to C-PDT • The significant better tolerability of FLEXI-PDT compared to C-PDT • A lower lesion complete response rate at three months for C-PDT (59.1%) lower than most rates reported in the literature due to a larger proportion of ─ less responsive to PDT ─ grade II AK in the present study

  12. Discussion http://www.phosistos.com/ • Limits of the study: • The unblinding of the study • The early termination of the study due to the initiation of the PHOS-ISTOS clinical study aiming to assess an improved version of FLEXI-PDT→ Reduction in the a priori statistical power of the study for the primary endpoint

  13. ConclusionsWhat does this study add? • This study demonstrates that the Flexitheralight protocol, which can be performed in all weather conditions, is equally effective as the conventional photodynamic therapy protocol for actinic keratosis and is a less painful technique.

  14. Call for correspondence • Why not join the debate on this article through our correspondence section? • Rapid responses should not exceed 350 words, four references and one figure. • Further details can be found here.

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