with aqueous cream although no significant difference was identified for MD rates. Miller et al Double blind CTCAE 176 Mometasone Breast CTCAE mean 1.2 + .85 + 2011 RCT version 3 Furoate (MMF) maximal grade intervention Skindex-16 vs. placebo and SD (range P=0.18 cream 0.0-3.0) 1.3 + 0.8 control Niazi et al Phase III RCT CTCAE 44 Sliver Clear Lower GI Skin toxicity on 1.67 (1.2 SD) P= 0.1 ++ 2012 - blinding not version 4 Nylon Dressing final fraction of intervention possible (SCND) radiotherapy. group vs. standard Mean skin care dermatitis and 2.53 (1.17 SD scores SD) control Graham et Double blind CTCAE 318 barrier cream Breast (post peak and medial/lateral p=0.047. + al 2013 RCT version 3 containing mastectomy) overall skin applications Photographic acrylate reactions using were audit terpolymer the CTCAE compared for (ATP) vs. a scoring tool the two 10% glycerine (version 3.0) products. In cream plus a the (Sorbolene) photographic proportion of audit of skin cases with ≥ scores to grade 3 skin confirm reaction, reactions there was a significant
with aqueous cream although no significant difference was identified for MD rates. Miller et al 2011 Double blind RCT CTCAE version 3 Skindex-16 176 Mometasone Furoate (MMF) vs. placebo cream Breast CTCAE mean maximal grade and SD (range 0.0-3.0) 1.2 + .85 intervention 1.3 + 0.8 control P=0.18 + Niazi et al 2012 Phase III RCT - blinding not possible CTCAE version 4 44 Sliver Clear Nylon Dressing (SCND) vs. standard skin care Lower GI Skin toxicity on final fraction of radiotherapy. Mean dermatitis and SD scores 1.67 (1.2 SD) intervention group 2.53 (1.17 SD) control P= 0.1 ++ Graham et al 2013 Double blind RCT CTCAE version 3 Photographic audit 318 barrier cream containing acrylate terpolymer (ATP) vs. a 10% glycerine cream (Sorbolene) Breast (post mastectomy) peak and overall skin reactions using the CTCAE scoring tool (version 3.0) plus a photographic audit of skin scores to confirm reactions medial/lateral applications were compared for the two products. In the proportion of cases with ≥ grade 3 skin reaction, there was a significant p=0.047. +
appendix_5_-_summary_of_evidence.docx