To hear about similar clinical trials, please enter your email below
Trial Title:
5fluorouracil for Advanced Photoaging
NCT ID:
NCT01405144
Condition:
Photoaging
Actinic Keratosis
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Skin Diseases
Fluorouracil
Conditions: Keywords:
Photoaging
Actinic keratosis
5-fluoruracil
Carcinogenesis
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
5-fluoruracil
Description:
5% 5-fluoruracil cream, twice a day, during 3 weeks
Arm group label:
5% 5-fluoruracil cream
Other name:
Topical treatment
Intervention type:
Procedure
Intervention name:
5-fluoruracil
Description:
The same 30 patients will be submitted to 4 weekly application of superficial peeling
using 5% 5-fluoruracil in propyleneglycol as vehicle. The applications will be performed
by physician (one of the co-investigators)
Arm group label:
5% 5-fluoruracil peeling
Other name:
Cosmetic procedure
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Edileia Bagatin
Address:
City:
Sao Paulo
Zip:
04075-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Carolina Zerbini, MD
Phone:
55-15-97280079
Email:
carolzerbini@hotmail.com
Investigator:
Last name:
Carolina Zerbini, MD
Email:
Principal Investigator
Start date:
August 2010
Completion date:
March 2012
Lead sponsor:
Agency:
Federal University of São Paulo
Agency class:
Other
Source:
Federal University of São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01405144
