New Protocol NonInferior to Conventional Treatment of AKs



A recent study demonstrated that a new treatment protocol for actinic keratoses had similar efficacy rates compared with the conventional treatment protocol, but lower patient-reported pain.

“Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp,” the researchers said. “However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are 2 limiting factors of this protocol.” To address these limits, the researchers examined the efficacy and tolerability of a new protocol, known as the Flexitheralight protocol, which involves irradiation using a light-emitting, fabric-based device.

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The study included 25 participants with grade I and II actinic keratoses on the forehead and scalp who were treated with methyl aminolevulinate photodynamic therapy in 2 symmetrical areas. A total of 154 actinic keratoses were treated with the conventional protocol using the Aktilite CL 128 lamp, and 156 actinic keratoses were treated with the Flexitheralight protocol. Complete response rate at 3 months was assessed as the primary endpoint, with an absolute non-inferiority margin of -10%. The secondary endpoint included patient reported pain at the end of irradiation.

After 3 months, the researchers observed that the complete response rate of lesions with the Flexitheralight protocol was noninferior to the conventional protocol (66% vs, 59.1%, respectively). However, patient-reported pain was significantly lower with the Flexitheralight protocol compared with the conventional protocol.

“The Flexitheralight protocol is non‐inferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating actinic keratoses of the forehead and scalp,” the researchers concluded.


Vicentini C, Vignion-Dewalle AS, Thecua E, et al. 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 [published online October 26, 2018]. Br J Dermatol. doi:10.1111/bjd.17350