Bazire, L., Fromantin, I., Diallo, A., Lande, B., Pernin, V., Dendale, R., . . . Kirova, Y.M. (2015). Hydrosorb^® versus control (water based spray) in the management of radio-induced skin toxicity: Results of multicentre controlled randomized trial. Radiotherapy and Oncology, 117, 229–233. 

To report the efficacy of Hydrosorb versus water-based spray (control) to treat G1-2 radiodermatitis in patients with early stage breast cancer (BC) treated with normo-fractionated radiotherapy (RT)

• Patients were randomized to either the (a) Hydrosorb arm or the (b) placebo arm if they had the presence of grade 1 or grade 2 radiodermatitis.
• Baseline colorimetric measurement was performed on healthy skin on day 0.
• Local placement of Hydrosorb was done by the research nurse for the first time with subsequent education on how to apply at home. 
• Study observations were conducted on days 7,14, 21, and 28.
• All patients were instructed in skin care: use of mild soap for cleansing and daily moisturizer, avoidance of pools and sunlight, use of razors or deodorant
• Patients were removed from the study for grade 3 or 4 dermatitis.

• N = 278 in intention to treat analysis
• MEDIAN AGE = 53 years
• AGE RANGE = 21–86 years
• MALES: Not stated  
• FEMALES: Not stated
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer. Three patients in the Hydrosorb arm had diabetes (2.1%), and six patients in the placebo group (4.4%).
• OTHER KEY SAMPLE CHARACTERISTICS: Age, body mass index, tobacco use, diabetes, neoadjuvant chemotherapy, radiodermatitis grade, median dose, medial colorimetric value, colorimetric value in two categories, median surface, pain, concurrent hormonal treatment

• SITE: Multicenter
• SETTING TYPE: Hospital
• LOCATION: France

PHASE OF CARE: Active treatment

Randomized, prospective, open-label, placebo-controlled study

• Dermatology Life Quality Index (DLQI) questionnaire 
• Colorimetric evaluation (chromameter)
• Visual analog scale (VAS) 
• Common Terminology Criteria for Adverse Events (CTCAE), version 3

• Sixty (49%) treatment interruptions/failures occurred in Hydrosorb arm versus 62 (51%) in the control arm (p = 0.58).
• Twenty-four patients discontinued RT for local care.
• No colorimetric difference existed between the two arms (p = 0.21).
• The average absolute reduction of colorimetric levels between day 28 and day 0 was 4. 
• The median surface area of radiation dermatitis zone on D28 was 4.04 (Hydrosorb) and 4 (placebo).
• The median VAS on D28 was 2 in both arms.
• Forty-eight patients in the Hydrosorb arm had a VAS score greater than 2 versus 51 patients in the placebo arm (i.e., 34% and 38%, respectively) (p = 0.45).
• Significant reduction of pain was observed on D7 (p = 0.04) and D21 (p = 0.01) in the Hydrosorb arm.
• Median quality of life (QOL) per DLQI on D28 was 5 in both arms.
• Sixty patients in the Hydrosorb arm and 55 patients in the placebo arm had moderately to severely altered QOL (p = 0.76).
• Skin care was considered to be satisfactory for 125 patients in the Hydrosorb arm (88%) and 116 patients in the placebo arm (85%) (p = 0.059).

No significant difference existed between Hydrosorb and placebo in the treatment of acute radioinduced dermatitis. A trend in improvement in pain was observed with the use of Hydrosorb; however, any additional treatment given for pain, which was allowed, was not described.

The ingredients of the patients' applied moisturizer were not defined and could have altered skin physiology in both arms. The frequency of Hydrosorb application was not defined. No actual grading of dermatitis existed per se. Changes in local treatment were allowed, but no information was provided regarding what additional treatments were done.

This study did not show that Hydrosorb was effective in preventing the increase of radiodermatitis severity. Patient instructions used here included outdated information, such as the need to avoid use of deodorants. Very limited evidence shows that topical treatments effectively prevent radiodermatitis.