Status:
UNKNOWN
5fluorouracil for Advanced Photoaging
Lead Sponsor:
Federal University of São Paulo
Conditions:
Photoaging
Actinic Keratosis
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
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 w...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01405144
Start Date
August 1 2010
End Date
March 1 2012
Last Update
July 29 2011
Active Locations (1)
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1
Edileia Bagatin
São Paulo, São Paulo, Brazil, 04075-000