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5fluorouracil for Advanced Photoaging

NCT ID: NCT01405144

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Photoaging Actinic Keratosis

Keywords

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Photoaging Actinic keratosis 5-fluoruracil Carcinogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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5% 5-fluoruracil cream

30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm

Group Type ACTIVE_COMPARATOR

5-fluoruracil

Intervention Type DRUG

5% 5-fluoruracil cream, twice a day, during 3 weeks

5% 5-fluoruracil peeling

The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm

Group Type ACTIVE_COMPARATOR

5-fluoruracil

Intervention Type PROCEDURE

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)

Interventions

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5-fluoruracil

5% 5-fluoruracil cream, twice a day, during 3 weeks

Intervention Type DRUG

5-fluoruracil

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)

Intervention Type PROCEDURE

Other Intervention Names

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Topical treatment Cosmetic procedure

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de Sao Paulo - Dermatology Department

Principal Investigators

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Ediléia Bagatin, PhD

Role: STUDY_CHAIR

Professor

Locations

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Edileia Bagatin

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Edileia Bagatin, phD

Role: CONTACT

Phone: 55-11-94448848

Email: [email protected]

Facility Contacts

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Carolina Zerbini, MD

Role: primary

Other Identifiers

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Carol2011

Identifier Type: -

Identifier Source: org_study_id