Photoaging, Actinic Keratosis
Conditions
Keywords
Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis
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.
Interventions
DRUG5-fluoruracil
5% 5-fluoruracil cream, twice a day, during 3 weeks
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Men and women, aged from 50 to 75 anos; 2. Phototype I a III (Fitzpatrick Classification); 3. Advanced photoaging on forearms, with multiple superficial actinic keratosis; 4. Agreement with no sun exposure during the study and 5. Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.
Exclusion criteria
1. 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; 2. Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months; 3. Treatment with systemic retinoid in the last 6 months ; 4. Chemotherapy in the last 3 months; 5. Hypersensibility to parabens; 6. Infectious or inflammatory dermatosis on forearms; 7. Clinical evidence of immunosuppression and 8. Presence of photodermatosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Photographic Evaluation | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Opinion | 0, 30, 60, 180 days | 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. |
| Inflammatory Skin Reaction | 30 day | Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry |
| Change in Forearm Photoaging Classification | 0, 60, 180 days | 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. |
| Change in Investigator Clinical Evaluation | 0, 30, 60, 180 days | 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 |
| Occurence and Evaluation of Adverse Events | 30, 60, 180 days | Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments |
Countries
Brazil
Contacts
Primary ContactEdileia Bagatin, phD
Outcome results
None listed