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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
Phase 4 trial testing 5-fluorouracil 4% (Tolak) in Actinic Keratoses in 146 participants. Completed in 31 January 2022.
31 January 2022
Quick facts
| Lead sponsor | Pierre Fabre Medicament |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 146 |
| Start date | 16 February 2021 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 January 2022 |
| Sites | 27 locations across France, Spain, Germany, Italy |
Drugs / interventions tested
- 5-fluorouracil 4% (Tolak) — full drug profile →
- Dexeryl — full drug profile →
Conditions studied
- Actinic Keratoses — all drugs for Actinic Keratoses →
Sponsor
Pierre Fabre Medicament — full company profile →
Who can join
18 and older, any sex, with Actinic Keratoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04875026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Actinic Keratoses
Currently open trials in the same condition.
- NCT06499415 — Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis · Phase 4 · recruiting
- NCT06385340 — Investigation of the Effect of Lipikar Baume AP+M · NA · recruiting
- NCT06321003 — SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography · recruiting
- NCT05202860 — Impact of Human Papillomavirus (HPV) Vaccination on Burden of Disease in Patients with Actinic Keratosis · Phase 2 · active not recruiting
- NCT05976061 — High- and Low-risk Actinic Keratosis Referrals to Secondary Care · active not recruiting
Other Pierre Fabre Medicament trials
Trials by the same sponsor.
- NCT06690489 — An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients · completed
- NCT06669117 — FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations · Phase 1, PHASE2 · recruiting
- NCT06688370 — The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study · terminated
- NCT06043817 — First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer H · Phase 1, PHASE2 · recruiting
- NCT07096206 — Characteristics and Impacts of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) in Boys: An Observational Internationa · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04875026 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pierre Fabre Medicament
- Last refreshed: 19 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04875026.
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