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Brief Title: 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
Official Title: 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
Study ID: NCT04875026
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Private practice Maire, Arras, , France
Chu de Nantes Hôtel-Dieu, Nantes, , France
CHU Pau, Pau, , France
CHU Poitiers, Poitiers, , France
CHU St Etienne Hopital Nord, Saint-Étienne, , France
Kath. Klinikum Bochum St. Josef-Hospital, Bochum, , Germany
MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, , Germany
Private Practice Kurzen, Freising, , Germany
Dermatologikum Hamburg, Hamburg, , Germany
Private practice Quist, Mainz-Bretzenheim, , Germany
Hautarztpraxis, Witten, , Germany
CentroDerm Clinic, Witten, , Germany
Uni Clinic Brescia, Brescia, , Italy
Uni Clinic Catania, Catania, , Italy
Uni Clinic L'Aquila, Coppito, , Italy
Policlinico San Martino, Genova, , Italy
University of Messina, Messina, , Italy
Uni Clinic Modena, Modena, , Italy
NAPLES VANVITELLI UNIVERSITI (Federico II Hospital), Napoli, , Italy
Azienda Unità Sanitaria Locale - IRCCS, Reggio Emilia, , Italy
Catholic University Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy
Sapienza University of Rome - Polo Pontino, Terracina, , Italy
Centre medic Congres, Barcelona, , Spain
Hospital Alfredo Espinosa, Bilbao, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Instituto Valenciano de Oncología,, Valencia, , Spain
Hospital Marina Baixa, Villajoyosa, , Spain
Name: Eggert STOCKFLETH, Pr.
Affiliation: Kath. Klinikum Bochum St. Josef-Hospital
Role: PRINCIPAL_INVESTIGATOR