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5fluorouracil for Advanced Photoaging

Primary Purpose

Photoaging, Actinic Keratosis

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
5-fluoruracil
5-fluoruracil
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photoaging focused on measuring Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Edileia BagatinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5% 5-fluoruracil cream

5% 5-fluoruracil peeling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Inflammatory Skin Reaction
Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry
Occurence and Evaluation of Adverse Events
Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments
Change in Patient Opinion
Patient opinion concerning modification on forearms skin overall aspect, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better, comparing day 0 to 60, 60 to 180 and 0 to 180.
Change in Investigator Clinical Evaluation
Investigator efficacy evaluation through actinic keratosis counting, on days 0, 30, 60 and 180 as weel as modification on forearms skin overall aspect. That will be performed by comparision of skin examination on days 60 and 180 to photography captured on days 0 and 60, i.e, 0 to 60, 60 to 180 and 0 to 180, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better
Change in Forearm Photoaging Classification
A classification will be created and validated by investigators and five independent observers previously to classify forearm photoaging. After validation it will be applied to study subjects on days 0, 60 and 180 to evaluate modification on the forearm photoaging grade for each tretament.

Full Information

First Posted
July 5, 2011
Last Updated
July 28, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01405144
Brief Title
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging, Actinic Keratosis
Keywords
Photoaging, Actinic keratosis, 5-fluoruracil, Carcinogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5% 5-fluoruracil cream
Arm Type
Active Comparator
Arm Description
30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm
Arm Title
5% 5-fluoruracil peeling
Arm Type
Active Comparator
Arm Description
The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm
Intervention Type
Drug
Intervention Name(s)
5-fluoruracil
Other Intervention Name(s)
Topical treatment
Intervention Description
5% 5-fluoruracil cream, twice a day, during 3 weeks
Intervention Type
Procedure
Intervention Name(s)
5-fluoruracil
Other Intervention Name(s)
Cosmetic procedure
Intervention 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)
Primary Outcome Measure Information:
Title
Change in Photographic Evaluation
Description
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
Time Frame
0, 60, 180 days
Title
Change in Microscopic Evaluation
Description
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.
Time Frame
0, 180 days
Secondary Outcome Measure Information:
Title
Inflammatory Skin Reaction
Description
Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry
Time Frame
30 day
Title
Occurence and Evaluation of Adverse Events
Description
Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments
Time Frame
30, 60, 180 days
Title
Change in Patient Opinion
Description
Patient opinion concerning modification on forearms skin overall aspect, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better, comparing day 0 to 60, 60 to 180 and 0 to 180.
Time Frame
0, 30, 60, 180 days
Title
Change in Investigator Clinical Evaluation
Description
Investigator efficacy evaluation through actinic keratosis counting, on days 0, 30, 60 and 180 as weel as modification on forearms skin overall aspect. That will be performed by comparision of skin examination on days 60 and 180 to photography captured on days 0 and 60, i.e, 0 to 60, 60 to 180 and 0 to 180, using a 5 point scale: -2=much worse; -1=worse; 0=inaltered; 1=better, 2= much better
Time Frame
0, 30, 60, 180 days
Title
Change in Forearm Photoaging Classification
Description
A classification will be created and validated by investigators and five independent observers previously to classify forearm photoaging. After validation it will be applied to study subjects on days 0, 60 and 180 to evaluate modification on the forearm photoaging grade for each tretament.
Time Frame
0, 60, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edileia Bagatin, phD
Phone
55-11-94448848
Email
edileia_bagatin@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ediléia Bagatin, PhD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Edileia Bagatin
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04075-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Zerbini, MD
Phone
55-15-97280079
Email
carolzerbini@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carolina Zerbini, MD

12. IPD Sharing Statement

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5fluorouracil for Advanced Photoaging

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