Subjects:
Twenty women aged =18 years receiving radiation therapy for breast cancer.


Objective:
To compare the efficacy and tolerability of Xclair™ Cream with a vehicle emollient cream without hyaluronic acid.


Methodology:

• This was a double-blind, randomized, placebo-controlled study comparing efficacy of Xclair™ Cream to a vehicle emollient cream based on incidence or severity of radiation dermatitis.
• After a 7-day pre-study washout phase, study medications were administered at least 3 times daily throughout radiation therapy and for 2 weeks afterward.
• The treatment area on each patient was divided into two vertical sections; Xclair™ Cream was applied to one side and vehicle to the other.
• Radiation therapy (total dose 50Gy to 70Gy) was administered to the breast or underlying chest wall (field not less than 15.25 cm) as divided daily fractions Monday through Friday for 4-6 weeks.
  Patients were monitored at baseline, weekly during radiation therapy, and for two weeks afterwards.
• Outcome measurements included: skin appearance; patient assessments of itch, pain, and medication tolerability; patient and investigator treatment preferences; incidence of adverse events; and need for delayed radiation therapy due to radiation dermatitis.

Findings:

• Use of Xclair™ Cream was associated with a lower NCI toxicity score compared to vehicle from week 3 to week 7 of treatment, reaching statistical significance at week 4.
• Erythema scores were significantly lower in patients treated with Xclair™ Cream than vehicle at weeks 4, 5, and 6.
• All itch scores and pain scores for Xclair™ Cream were zero. Although a few scores greater than zero were recorded for vehicle, there was no significant difference between treatments for pain, itch, or skin hydration.
• Patients considered Xclair™ Cream significantly superior to vehicle (P=0.006) in perceived effect on dermatitis.
• Both patients (P=0.007) and investigators (P=0.035) preferred Xclair™ Cream to vehicle.
• No adverse events or interruptions of therapy were reported.

Conclusions:
Xclair™ Cream is an effective, well-tolerated option for managing symptoms of radiation dermatitis. ³⁶

Subjects:
152 patients receiving radiation therapy for head and neck, breast, or pelvic carcinoma.


Objective:
To compare the effect of hyaluronic acid 0.2% cream (Ialugen) with a placebo cream that contained no hyaluronic acid.


Methodology:

• Patients received either a conventional fractionation schedule daily (head and neck, breast, pelvic) or a hyperfractionated schedule with two daily sessions with a minimum of 6 hour interval (head and neck).
• Placebo (PBO) or Ialugen cream (IA) was applied to the irradiated skin area twice a day over the 6-week treatment period. Patients were instructed to apply the cream during the weekends.
• Patients were examined on admission (Day 0) and once a week by the same physician over a 10-week period (6-week treatment period and 4-week follow up period).
• The status of irradiated skin surface was assigned a score from 0 (normal skin) to 5 (ulcer).

Findings:

• Acute radiation dermatitis scores were significantly higher in the PBO group than the IA group throughout the 6 weeks of treatment (P<0.01 weeks 3-7; P<0.05 at weeks 8 and 10).
• In the PBO group, 6 patients had acute skin reactions; 5 patients scored 4 and one scored 5 (ulceration). In the IA group, only one patient had a severe skin reaction.
• A global judgment on the therapeutic efficacy was statistically significant in favor of the IA group, as rated by both physician (P<0.01) and patient (P<0.05).
• In the subgroup of patients with head and neck cancers (n=90), IA was significantly superior to PBO at week 3 (P=0.0003), week 4, (P=0.0001), and week 5 (P=0.0035).
• The incidence of radiation dermatitis with scores >1 decreased more rapidly in the IA than PBO, indicating that hyaluronic acid accelerates healing of irradiated skin.
• Both treatments were well tolerated.

Conclusions:
“…the application of Ialugen cream on the irradiated skin area during radiation therapy was shown to postpone the first signs of acute epitheliitis and reduce the severity of skin reactions. Moreover, the fact that the time to recover was longer in patients treated with placebo cream, indicates that hyaluronic acid was effective not only as a prophylactic but also as a therapeutic measure…” ²⁷


Marketing note:
Although IA in this study was applied similarly to Xclair™ Cream in the study by Primavera et al (ie, every day during therapy), the authors of this study refer to such use as prophylactic use. Prophylactic use of Xclair™ Cream, however, is not an approved indication for this product.