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5fluorouracil for Advanced Photoaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405144
Recruitment Status : Unknown
Verified May 2011 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Information provided by:
Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Photoaging Actinic Keratosis Drug: 5-fluoruracil Procedure: 5-fluoruracil Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : August 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Photographic Evaluation [ Time Frame: 0, 60, 180 days ]
    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

  2. Change in Microscopic Evaluation [ Time Frame: 0, 180 days ]
    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 :
  1. Inflammatory Skin Reaction [ Time Frame: 30 day ]
    Comparison between treatments on inflammatory skin reaction will be performed by expression of interleucin-1, using immunohistochemistry

  2. Occurence and Evaluation of Adverse Events [ Time Frame: 30, 60, 180 days ]
    Predictable and unpredictable side effects and their intensity related by patient and/or observed by investigator will be analized and compared between the treatments

  3. Change in Patient Opinion [ Time Frame: 0, 30, 60, 180 days ]
    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.

  4. Change in Investigator Clinical Evaluation [ Time Frame: 0, 30, 60, 180 days ]
    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

  5. Change in Forearm Photoaging Classification [ Time Frame: 0, 60, 180 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405144

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Contact: Edileia Bagatin, phD 55-11-94448848

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Edileia Bagatin Recruiting
Sao Paulo, SP, Brazil, 04075-000
Contact: Carolina Zerbini, MD    55-15-97280079   
Principal Investigator: Carolina Zerbini, MD         
Sponsors and Collaborators
Federal University of São Paulo
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Study Chair: Ediléia Bagatin, PhD Professor
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Responsible Party: Edileia Bagatin, Universidade Federal de Sao Paulo - Dermatology Department Identifier: NCT01405144    
Other Study ID Numbers: Carol2011
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: May 2011
Keywords provided by Federal University of São Paulo:
Actinic keratosis
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs