NCT01405144

5fluorouracil for Advanced Photoaging

Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported. The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.

Detailed description

The use of 5% 5-fluorouracil (5-FU) cream, twice a day, during 3 weeks represents a classic treatment for multiple and superficial AKs. The main adverse event is the severe skin irritation leading to interruption of the treatment in some cases. In the last decade a superficial pulse-peeling using it as agent in sequential applications was described. This modality of treatment has been demonstrated efficacy and better tolerability. The improvement of the overall aspect of photodamaged skin is observed while treating multiple AKs. There are no comparative study between the two types of 5% 5-FU use. So that is the purpose of our clinical trial.

Conditions

• Photoaging
• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	5-fluoruracil	5% 5-fluoruracil cream, twice a day, during 3 weeks
PROCEDURE	5-fluoruracil	The same 30 patients will be submitted to 4 weekly application of superficial peeling using 5% 5-fluoruracil in propyleneglycol as vehicle. The applications will be performed by physician (one of the co-investigators)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2011-07-29
• Last updated: 2011-07-29

Locations

1 site across 1 country: Brazil