drugset / Trial / NCT04875026

Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

NCT04875026

Phase 4 Completed 146 enrolled Pierre Fabre Laboratories Clinact · collab
RandomizedParallel-groupSingle-blindSupportive care

Summary

Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream. The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.

Timeline

Start
2021-02-16
Primary completion
2022-01-31
Completion
2022-01-31

Drugs

EvaluationDrugModalityDoseRoute
Background fluorouracil Small molecule 4 % Topical

Indications