NCT01405144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 29, 2011

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

July 5, 2011

Last Update Submit

July 28, 2011

Conditions

PhotoagingActinic Keratosis

Keywords

PhotoagingActinic keratosis5-fluoruracilCarcinogenesis

Outcome Measures

Primary Outcomes (2)

  • Change in Photographic Evaluation

    Photographic blinded evaluation by two independent observers, comparing modifications of forearms skin overall aspect before and after 60 and 180 days of the treatments. The following 5 point scale will be used: -2=much worse; -1=worse; 0=inlatered; 1=better, 2= much better

    0, 60, 180 days

  • Change in Microscopic Evaluation

    Skin biopsies will be performed and coloration by hematoxilin-eosin, Verhoeff, Tricromio Masson , Picrosirius and biomarkers (p53, bcl2, collagen 1)will be used. The modifications on corneal layer and epidermal thickness, dermal elastotic material and collagen deposition and biomarkers expression will be evaluated by digital quantitative analysis, comparing the findings before (day 0) and after (day 180)treatments.

    0, 180 days

Secondary Outcomes (5)

  • Inflammatory Skin Reaction

    30 day

  • Occurence and Evaluation of Adverse Events

    30, 60, 180 days

  • Change in Patient Opinion

    0, 30, 60, 180 days

  • Change in Investigator Clinical Evaluation

    0, 30, 60, 180 days

  • Change in Forearm Photoaging Classification

    0, 60, 180 days

Study Arms (2)

5% 5-fluoruracil cream

ACTIVE COMPARATOR

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

Drug: 5-fluoruracil

5% 5-fluoruracil peeling

ACTIVE COMPARATOR

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

Procedure: 5-fluoruracil

Interventions

5-fluoruracilDRUG

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

Also known as: Topical treatment
5% 5-fluoruracil cream

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Men and women, aged from 50 to 75 anos;
  • Phototype I a III (Fitzpatrick Classification);
  • Advanced photoaging on forearms, with multiple superficial actinic keratosis;
  • Agreement with no sun exposure during the study and
  • Agreement with study conditions,capacity to understand and follow the orientations and form consent signature.

You may not qualify if:

  • 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;
  • Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months;
  • Treatment with systemic retinoid in the last 6 months ;
  • Chemotherapy in the last 3 months;
  • Hypersensibility to parabens;
  • Infectious or inflammatory dermatosis on forearms;
  • Clinical evidence of immunosuppression and
  • Presence of photodermatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edileia Bagatin

São Paulo, São Paulo, 04075-000, Brazil

RECRUITING

MeSH Terms

Conditions

Keratosis, ActinicCarcinogenesis

Interventions

TherapeuticsCosmetics

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Ediléia Bagatin, PhD

    Professor

    STUDY CHAIR

Central Study Contacts

Edileia Bagatin, phD

CONTACT

55-11-94448848edileia_bagatin@yahoo.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 29, 2011

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

July 29, 2011

Record last verified: 2011-05

Locations

BR(1)