Objective

To compare the efficacy and safety of Dexeryl emollient cream versus Trolamine in the management of post-radiotherapy erythema.

Study

Phase III, single-center, randomized (contralateral), double-blind study of Dexeryl emollient cream versus Trolamine 0.67% (reference product).

Population

80 adult patients randomized: 70 breast cancer/10 ENT cancer.

Dosage

3 applications daily.

Duration

12-week duration: 3 applications per day during the first 6 weeks of radiotherapy, then 6 weeks after its cessation.

Primary endpoint

Trophic aspect of treated skin surfaces at D42 (end of radiotherapy) assessed by clinical signs (pain, erythema, exulceration, exudation) using a semi-quantitative scale with 4 scores (0=absent, 1=light, 2=moderate, 3=severe) and a visual analog scale assessing overall trophic aspect of the skin (0: skin lesion - 100: no skin lesion).

Secondary evaluation criteria

Clinical presentation of treated skin surfaces at D7, D14, D21, D28, D35 and D84 (same parameters as at D42).
Mean time to onset of first skin lesions.
Treatment efficacy assessed by the patient using a visual analog scale.
Mean time to disappearance of skin lesions between D42 and D84.
Acceptability and ease of use of both treatments assessed on D7, D42 and D84 along 3 axes: ease of application, penetration quality and sensation after application.
Final evaluation of treatments on D84 along 5 axes: treatment efficacy, treatment tolerance, treatment failure in terms of non-adherence, inefficacy and adverse events, preference for one of the treatments and residual hyperpigmentation.

Tolerance

Tolerance was satisfactory for both products.

Conclusion

Significant reduction in the severity of radiation-induced erythema.