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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-09-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Clinact

    collaborator OTHER

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Eggert STOCKFLETH, Pr. · Kath. Klinikum Bochum St. Josef-Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875026 on ClinicalTrials.gov