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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Photographic Evaluation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Men and women, aged from 50 to 75 anos;
- •Phototype I a III (Fitzpatrick Classification);
- •Advanced photoaging on forearms, with multiple superficial actinic keratosis;
- •Agreement with no sun exposure during the study and
- •Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.
Exclusion Criteria
- •Topical treatment with:
- •tretinoin in the last 6 months ;
- •other retinoids, alpha-hydroxyacids, poli-hydroxyacids, beta-hydroxyacids and ascorbic acid in the last 3 months;
- •Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months;
- •Treatment with systemic retinoid in the last 6 months ;
- •Chemotherapy in the last 3 months;
- •Hypersensibility to parabens;
- •Infectious or inflammatory dermatosis on forearms;
- •Clinical evidence of immunosuppression and
- •Presence of photodermatosis
Arms & Interventions
5% 5-fluoruracil cream
30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm
Intervention: 5-fluoruracil (Procedure)
5% 5-fluoruracil peeling
The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm
Intervention: 5-fluoruracil (Procedure)
Outcomes
Primary Outcomes
Change in Photographic Evaluation
Time Frame: 0, 60, 180 days
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
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.
Secondary Outcomes
- Inflammatory Skin Reaction(30 day)
- Occurence and Evaluation of Adverse Events(30, 60, 180 days)
- Change in Patient Opinion(0, 30, 60, 180 days)
- Change in Investigator Clinical Evaluation(0, 30, 60, 180 days)
- Change in Forearm Photoaging Classification(0, 60, 180 days)