Schmuth, M., Wimmer, M.A., Hofer, S., Sztankay, A., Weinlich, G., Linder, D.M., . . . Fritsch, E. (2002). Topical corticosteroid therapy for acute radiation dermatitis: A prospective, randomized, double-blind study. British Journal of Dermatology, 146, 983–991.

To compare treatment with topical 0%–1% methylprednisolone versus 0%–5% dexpanthenol and historical controls in a cohort of patients undergoing fractionated radiation therapy

After obtaining baseline data on an initial control cohort of untreated patients (n = 15), a subsequent cohort of patients was randomized to either 0%–1% methylprednisolone aceponate cream or 0%–5% dexpanthenol cream. Patients were instructed to apply the assigned cream twice daily from initiation of radiation therapy and for a two-week period after completion. No other topical medications, emollients, or powders were used during this period.

• The study sample was comprised of historical controls as well as patients using methylprednisolone aceponate cream (n = 10) and patients using dexpanthenol (n = 11).
• Mean age of the methylprednisolone group, dexpanthenol group, and historical controls was 62, 44, and 55 years, respectively, with a range of 39–75 years, 35–74 years, and 29–75 years, respectively.
• All patients were women with breast cancer.

The study took place at the University of Innsbruck in Austria.

The study used a prospective randomized double-blind study design with comparison to historical controls.

• Patients were assessed immediately prior to initiation of radiation therapy and weekly thereafter or erythema, desquamation, erosion, induration, and hyperpigmentation on a four-point scale: none (0) to severe (3). The total clinical score was a sum of individual ratings.
• To assess the impact of radiation therapy on epidermal barrier function, transepidermal water loss was measured weekly over four different areas within the irradiated field (one test per quadrant) and over one control area on the volar forearm using an evaporimeter.
• Recordings were not taken over skin showing extensive erosions.
• Quality of life was measured at the beginning of radiation therapy and after completion of the follow-up period to evaluate skin-specific (Skindex) and general outcome measures (SF-36).

Comparison of treatment groups with the historical, untreated control group suggested that either of the two topical regimens was superior to no treatment with respect to transepidermal water loss measurements, but not statistically significant. Transepidermal water loss levels did not differ between patients who received adjuvant chemotherapy and those who did not. There were no differences in quality-of-life findings. No quality-of-life data were obtained from untreated individuals in the preliminary cohort group. Skindex scores showed appearance of radiation dermatitis in virtually all participants. The dexpanthenol group showed deterioration that reached statistical significance for dimensions of depression, embarrassment, discomfort, and limitations (p < 0.05).

Prophylactic and ongoing use of topical therapy with topical corticosteroid or dexpanthenol-containing emollient does not prevent radiation dermatitis.

• The study sample was small.
• The 36-SF has been used to assess qualityo f life in patients with acne and psoriasis but not patients with radiation dermatitis.
• Skindex has been used to assess quality of life in a variety of dermatologic conditions, but not specifically used for radiation dermatitis.
• Median age of patients vary by 18 years, with an older median in methylprednisolone group.
• Scale for dermatitis grading is difficult to compare to standard scales used for radiation therapy-induced dermatitis.