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.
Graph showing the intensity of erythema at 42 days, depending on the product used. 1- Minor erythema. 2- Moderate erythema. 3- Severe erythema. Graphic created by Pierre Fabre.
