Graham, P.H., Plant, N., Graham, J.L., Browne, L., Borg, M., Capp, A., . . . Zissiadis, Y. (2013). A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: Trans Tasman Radiation Oncology Group (TROG) 04.01. International Journal of Radiation Oncology, Biology, Physics, 86, 45–50.
A previous unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine (sorbolene) cream. The different appearances of these products precluded a blinded comparison. To test the ATP principle in a double-blind manner required use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC). This study tested the hypothesis that an ATP alcohol-free barrier film reduces the degree of radiation skin reaction compared with the 10% glycerine cream most commonly used for this purpose in women receiving postmastectomy radiation therapy in Australia.
The chest wall was divided into medial and lateral compartments, and patients were randomized to receive MDBC applied daily to the medial or lateral side and sorbolene to the other side. Patients were instructed to apply the separate creams daily at the start of radiation to each half of the area on the chest wall receiving radiation therapy and to continue until two weeks after radiation completion. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected until week 12, or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters (TLDs).
The MDBC did not reduce peak skin reaction compared to sorbolene. It is possible that this is related to the difference in formulation of the cream compared with film formulation.
This study emphasizes the requirement for well-designed, appropriately powered, and controlled studies for skin care products. This study also potentially emphasizes that skin care products can vary in effectiveness based on formulation.