A Parallel, Observer Blind Study of the Skin Protection Properties of Silicone-Based Gels after Radiotherapy Exposure
Snyman JR 1*, Laurens I1, 2, Snyman KR3 and Oelofse I4
Progress in Medical Sciences. 2021;
Objective: Radiotherapy of cancers are usually accompanied by some form of radiation induced skin toxicity
(radiation dermatitis) in most patients receiving this type of treatment. It can vary from very mild disease to
extensive and severe dermatitis limiting further treatment. It is therefore obvious that preventative care will
optimise the outcome of radiation of the tumour while the skin’s integrity is preserved leading to a better
clinical outcome overall.
Methods: In Vitro: In the study a newly developed silicone topical device (RT-Gel Sun Pharma South Africa),
is compared to a similar product StrataXRT as well as to a negative control group of no gel. Gels were tested
to observe the effect on the radiation dose provided. All gels were applied as a thin layer to the surface of
the bolus within the Farmer Chamber.
In Vivo: In this multicentre study a newly developed silicone topical device (RT-Gel® Sun Pharma South
Africa), applied as a thin layer gel, is compared to a similar product StrataXRT as well as to standard of care
in practice. The aim was to compare patients’ preferences of treatment modalities as well as establishing
differences in clinical outcomes focussing on grades of skin toxicity after radiation therapy. Patients were
recruited at radiation oncology sites after being prescribed radiation dosages with curative intent for mostly
breast and head and neck cancers.
Results: In Vitro: The uncertainties pertaining to the theoretical dose changes and radiation measurements
indicates clearly the differences caused by the application of a silicone-based gel during radiotherapy is small
enough to be regarded as negligible.
In Vivo: The primary outcomes demonstrate the patient’s satisfaction with RT-Gel® i.e. a significant preference
for RT-Gel compared to both StrataXRT® (p< 0.02) and standard of care (p< 0.001). The clinicians’ toxicity
scores also favoured RT-Gel® over StrataXRT (p< 0.04 ANOVA).
Conclusion: It can thus be concluded that preventative treatment with RT-Gel® is at least as effective if not better
than competitors, well tolerated and preferred by patients. . It furthermore indicates that dose is not affected by
gel and that washing of treated area before next treatment is not required to “prevent build-up of gel”.