5fluorouracil for Advanced Photoaging

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01405144
First received: July 5, 2011
Last updated: July 28, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Photoaging
Actinic Keratosis
Drug: 5-fluoruracil
Procedure: 5-fluoruracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Change in Photographic Evaluation [ Time Frame: 0, 60, 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry

  • Occurence and Evaluation of Adverse Events [ Time Frame: 30, 60, 180 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0, 30, 60, 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 30, 60, 180 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 60, 180 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5% 5-fluoruracil cream
30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm
Drug: 5-fluoruracil
5% 5-fluoruracil cream, twice a day, during 3 weeks
Other Name: Topical treatment
Active Comparator: 5% 5-fluoruracil peeling
The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm
Procedure: 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)
Other Name: Cosmetic procedure

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405144

Contacts
Contact: Edileia Bagatin, phD 55-11-94448848 edileia_bagatin@yahoo.com.br

Locations
Brazil
Edileia Bagatin Recruiting
Sao Paulo, SP, Brazil, 04075-000
Contact: Carolina Zerbini, MD    55-15-97280079    carolzerbini@hotmail.com   
Principal Investigator: Carolina Zerbini, MD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Ediléia Bagatin, PhD Professor
  More Information

No publications provided

Responsible Party: Edileia Bagatin, Universidade Federal de Sao Paulo - Dermatology Department
ClinicalTrials.gov Identifier: NCT01405144     History of Changes
Other Study ID Numbers: Carol2011
Study First Received: July 5, 2011
Last Updated: July 28, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Photoaging
Actinic keratosis
5-fluoruracil
Carcinogenesis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014