5fluorouracil for Advanced Photoaging
Photoaging - Actinic Keratosis
Conditions: official terms
Keratosis - Keratosis, Actinic
Conditions: Keywords
Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Name: 5-fluoruracil Type: Drug
Name: 5-fluoruracil Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 75 Years
Minimum Age: 50 Years
Gender: Both
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
Edileia Bagatin
Sao Paulo, SP, Brazil
Status: Recruiting
Contact: Carolina Zerbini, MD - 55-15-97280079 - carolzerbini@hotmail.com
Start Date
August 2010
Completion Date
March 2012
Federal University of São Paulo
Federal University of São Paulo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page