Clinical trial NCT01405144: 5fluorouracil for Advanced Photoaging
Official title: Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Photoaging
Actinic Keratosis
Keywords: Photoaging
Actinic keratosis
5-fluoruracil
Carcinogenesis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Photographic Evaluation
timeFrame: 0, 60, 180 days
measure: Change in Microscopic Evaluation
timeFrame: 0, 180 days
Secondary outcomes:
measure: Inflammatory Skin Reaction
timeFrame: 30 day
measure: Occurence and Evaluation of Adverse Events
timeFrame: 30, 60, 180 days
measure: Change in Patient Opinion
timeFrame: 0, 30, 60, 180 days
measure: Change in Investigator Clinical Evaluation
timeFrame: 0, 30, 60, 180 days
measure: Change in Forearm Photoaging Classification
timeFrame: 0, 60, 180 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Edileia Bagatin
state: SP
Study officials:
affiliation: Professor
name: Ediléia Bagatin, PhD
role: STUDY_CHAIR
References: