5fluorouracil for Advanced Photoaging
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change in Photographic Evaluation [ Time Frame: 0, 60, 180 days ] [ Designated as safety issue: No ]Photographic blinded evaluation by two independent observers, comparing modifications of forearms skin overall aspect before and after 60 and 180 days of the treatments. The following 5 point scale will be used: -2=much worse; -1=worse; 0=inlatered; 1=better, 2= much better
- Change in Microscopic Evaluation [ Time Frame: 0, 180 days ] [ Designated as safety issue: No ]Skin biopsies will be performed and coloration by hematoxilin-eosin, Verhoeff, Tricromio Masson , Picrosirius and biomarkers (p53, bcl2, collagen 1)will be used. The modifications on corneal layer and epidermal thickness, dermal elastotic material and collagen deposition and biomarkers expression will be evaluated by digital quantitative analysis, comparing the findings before (day 0) and after (day 180)treatments.
- Inflammatory Skin Reaction [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry
- Occurence and Evaluation of Adverse Events [ Time Frame: 30, 60, 180 days ] [ Designated as safety issue: Yes ]Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments
- Change in Patient Opinion [ Time Frame: 0, 30, 60, 180 days ] [ Designated as safety issue: No ]Patient opinion concerning modification on forearms skin overall aspect, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better, comparing day 0 to 60, 60 to 180 and 0 to 180.
- Change in Investigator Clinical Evaluation [ Time Frame: 0, 30, 60, 180 days ] [ Designated as safety issue: No ]Investigator efficacy evaluation through actinic keratosis counting, on days 0, 30, 60 and 180 as weel as modification on forearms skin overall aspect. That will be performed by comparision of skin examination on days 60 and 180 to photography captured on days 0 and 60, i.e, 0 to 60, 60 to 180 and 0 to 180, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better
- Change in Forearm Photoaging Classification [ Time Frame: 0, 60, 180 days ] [ Designated as safety issue: No ]A classification will be created and validated by investigators and five independent observers previously to classify forearm photoaging. After validation it will be applied to study subjects on days 0, 60 and 180 to evaluate modification on the forearm photoaging grade for each tretament.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 5% 5-fluoruracil cream
30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm
5% 5-fluoruracil cream, twice a day, during 3 weeks
Other Name: Topical treatment
Active Comparator: 5% 5-fluoruracil peeling
The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm
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)
Other Name: Cosmetic procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405144
|Sao Paulo, SP, Brazil, 04075-000|
|Study Chair:||Ediléia Bagatin, PhD||Professor|