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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Outcome measures

    The main efficacy outcome is remission status. Four studies determined this with dermoscopic or histological assessment (Carrozzo, 2013; Carrozzo, 2014; Castellucci, 2021; Cipriani, 2022); 2 studies did not report the method used to determine remission status (Cipriani, 2017; Sedda, 2008).

    One study used the Common Terminology Criteria for Adverse Events (CTCAE 5.0) to grade early skin toxicity (Castellucci, 2017). This tool presents sets of criteria against each category of adverse event or symptom that is commonly caused by cancer treatments (for example, erythema). The criteria enable clinicians to make standardised assessments of the severity of the adverse event against descriptions of the event. The descriptions are marked against graded severity ratings from grade 1 (mild) to 5 (death related or due to adverse event).

    One study used the Radiation Therapy Oncology Group criteria (RTOG) to evaluate cosmetic results (Castellucci, 2017). This scale describes cosmetic changes to the skin. It ranges from poor (for example, ulceration or necrosis) to excellent (for example, no changes or slight pigment change).