5fluorouracil for Advanced Photoaging

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Fluorouracil

Criteria

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