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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
5% 5-fluoruracil cream, twice a day, during 3 weeks
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)
Edileia Bagatin
São Paulo, São Paulo, Brazil
RECRUITINGChange in Photographic Evaluation
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
Time frame: 0, 60, 180 days
Change in Microscopic Evaluation
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.
Time frame: 0, 180 days
Inflammatory Skin Reaction
Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry
Time frame: 30 day
Occurence and Evaluation of Adverse Events
Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments
Time frame: 30, 60, 180 days
Change in Patient Opinion
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.
Time frame: 0, 30, 60, 180 days
Change in Investigator Clinical Evaluation
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
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Time frame: 0, 30, 60, 180 days
Change in Forearm Photoaging Classification
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.
Time frame: 0, 60, 180 days