DEXERYL: AN EFFECTIVE TREATMENT FOR RADIOTHERAPY-RELATED ERYTHEMA

METHODOLOGY

Aim

To compare the activity and tolerability of DEXERYL versus Trolamine in the management of post-radiotherapy erythema.  

Study

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

Population

80 randomised adult patients: 70 with breast cancer/10 with ENT cancer.

Dosage

3 applications daily.

Duration

Duration of 12 weeks: 3 applications per day during the first 6 weeks of radiotherapy and then 6 weeks after it has finished.

Primary evaluation criteria

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=slight, 2=moderate, 3=severe) and a visual analogue scale assessing the 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)
• Average time to first skin lesions
• Treatment efficacy assessed by the patient using a visual analogue scale
• Average time of disappearance of skin lesions between D42 and D84
• Acceptability and ease of use of the two treatments evaluated on D7, D42 and D84 according to 3 criteria: ease of application, quality of penetration and sensation after application
• Final evaluation of treatments on D84 according to 5 criteria: treatment efficacy, treatment tolerance, treatment failure in terms of non-compliance, inefficacy and adverse events, preference for one of the treatments and residual hyperpigmentation.

Tolerance

Tolerance is satisfactory for both products.

Sources:   

1- Monnier A. Study of the activity and tolerance of DEXERYL cream versus Trolamine in the treatment of erythema resulting from radiotherapy. Clinical study report DC569 B98 CR301.