Omidvari, S., Saboori, H., Mohammadianpanah, M., Mosalaei, A., Ahmadloo, N., Mosleh-Shirazi, M.A., . . . Namaz, S. (2007). Topical betamethasone for prevention of radiation dermatitis. Indian Journal of Dermatology, Venereology and Leprology, 73, 209–214.

To investigate whether the prophylactic use of topical betamethasone 0.1% can prevent acute radiation dermatitis

Patients were randomly assigned to one of three groups: betamethasone, petrolatum, or no treatment. The treatment delivery protocol was the same for all groups. Education on the amount of skincare product to use was consistent.

• The study sample (N = 51) was comprised of female patients with breast cancer (stage I or II).
• Age of the sample ranged from 34–66 years.
• Patients did not undergo concurrent chemotherapy or systemic corticosteroids.
• The total radiation dose was 50 Gy to the chest wall, with patients receiving a single 2 Gy per day for five days a week.
• A cobalt-60 unit was used, which does not have the same skin-sparing abilities of the 3-D conformal or intensity-modulated radiation therapy.

The study used a randomized double-blind controlled trial design.

• Patients were assessed using the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria for acute radiation dermatitis.
• Statistical analysis was done using non-parametrical tests (Kruskal-Wallis test and Friedman test).

By the third week (30 Gy), 26.3% of the betamethasone group had grade 1 skin toxicity compared to 64.7% and 66.7% of the petroleum and control groups, respectively (p = 0.027). By the seventh week, 15.8% of the betamethasone patients had grade I skin toxicity, 6.7% of the control group had grade I, and 100% of the petroleum group had grade II or higher.

Acute radiation dermatitis increased over time for all groups. The betamethasone group had lower prevalence at one time point; however, at the end of treatment, acute radiation dermatitis was lower in the untreated controls.

• Skin assessment did not include the inframammary fold.
• No statement if a patient missed a treatment.
• Patient perceptions, such as pain or itching, were not addressed.
• Though the study stated the aim was to prevent acute radiation dermatitis, more than 90% of the sample had grade 2 or higher acute radiation dermatitis at the beginning of the study.
• The study had no blinding and a small sample size, with less than 100 participants.