Pardo Masferrer, J., Murcia Mejía, M., Vidal Fernández, M., Alvarado Astudillo, A., Hernández Armenteros, M. L., Macías Hernández, V., . . . Mirada Ferre, A. (2010). Prophylaxis with a cream containing urea reduces the incidence and severity of radio-induced dermatitis. Clinical and Translational Oncology, 12, 43–48.

Primary Aim:  To evaluate the effectiveness of author-defined intensive use (three times daily [TID] use starting two or three weeks before radiotherapy [RT] and continuing this frequency throughout RT) application of a lotion preparation made of 3% urea, polidocanol, and hyaluronic acid for preventing the appearance of acute radiodermatitis and controlling its severity in patients actively undergoing RT for breast cancer.

Secondary Aim:  To study effectiveness, the authors compared the incidence and grade of toxicity with 174 patients with breast cancer treated in the same clinic the previous year. These patients used skin-support measures at the beginning of RT or when radiodermatitis occurred.

Ureadin cream was used TID for two to three weeks prior to the start of external beam RT (EBRT) and continued for the entire treatment period. This use was considered intensive compared to other studies and the standard use schedule of twice daily (BID) cream application at the start of RT or 10 days before starting RT.

• The sample was comprised of 98 women with breast cancer.
• Mean age was 59 years (range 57–61).
• Patients were treated with conservative surgery and scheduled to start EBRT with a 10-week follow-up period. 
• The RT field included the entire mammary gland; maximum dose was 50 Gy in 25 fractions of 2 Gy each day, followed by an electron boost to the surgical bed to a total dose 60 to 70 Gy.
• One patient had RT to the internal mammary lymph nodes.
• RT was interrupted in two patients; one was due to grade 3 radiodermatitis (14-day interruption) and one required vertebroplasty (40-day interruption).

• Single site  
• Outpatient
• Radiation Oncology Department, Hospital General de Catlunya, Spain

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

This was a prospective, observational study performed over 14 months.

• Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) acute toxicity scale:  weekly evaluation
• Visual analog scale (VAS) for patients to rate pain, itching, redness, desquamation, and effect on quality of life (QOL)
• Numeric scale (0–3) for patients and physicians to rate effectiveness, tolerability, and cosmetic properties of the lotion (0 = poor; 1 = moderate; 2 = good; 3 = excellent). Also, patients were asked to give an overall score out of 10.

The overall rate of radiodermatitis was 72.4%, with 51% of patients being toxicity grade 1; 20% grade 2, and 1% grade 3. The first case of skin toxicity appeared in third week of treatment; in >87% of patients, radiodermatitis appeared between weeks 5 and 7. The severity of radiodermatitis with the intensive use of the lotion was significantly lower (72.4% vs. 84.5%; p < 0.05). The grade of toxicity was significantly lower in intensive-use patients (p < 0.001), and grade 2 toxicity or higher was significantly lower (21.4% vs. 50%; p < 0.01). Severity of clinical symptoms of pain, itching, redness, desquamation, and impact on QOL was reported as negligible by patients.

For patients with breast cancer who undergo conservative surgery and will receive RT to a dose of 60 to 70 Gy, use of Ureadin on an intensive basis (TID beginning two to three weeks prior to the start of RT) compared to BID use is considered effective at reducing the incidence and grade of skin toxicity during RT and is well tolerated by patients.

•  The study had a small sample size, with less than 100 patients.
•  The study lacked an appropriate control group.

1. Intensive use of skin care preparation two to three weeks prior to starting RT seems effective at reducing the incidence of skin toxicity and probably increases better tolerance to RT for patients with breast cancer.
2. The ingredients in this lotion (urea, hyaluronic acid, and polidocanol) seem effective in keeping irradiated skin hydrated and lessening reports of pain, redness, and itching experienced by patients undergoing EBRT to the breast.
3. It is possible that these findings could be useful for other cancer diagnoses for patients undergoing EBRT.
4. The cost burden to patients would need to be studied; if patients are starting a prophylactic skin care regimen two to three weeks before RT, during the six to seven weeks of RT, and for one to two weeks after RT, is it cost-effective to prescribe this regimen routinely? (Online search of amazon.com showed Ureadin-Iralfaris-lotion supplied as 250 mL for $30.95).
5. Depending on the type of cancer, date of simulation, and start date for RT, it may not be feasible to start this skin care regimen two to three weeks prior to start of RT.
6. It would be interesting to compare the effectiveness of Ureadin to US commercial preparations containing hyaluronic acid (i.e., XClair, Miaderm, or Biafine).