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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	5-fluorouracil 4% (Tolak)	Application of Tolak once daily in the evening for 4 weeks
DEVICE	Dexeryl	Application of Dexeryl once daily in the morning for 8 weeks

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2021-05-06
• Last updated: 2022-09-19

Locations

27 sites across 4 countries: France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study