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Clinical Trials/NCT01405144
NCT01405144UnknownPhase 3

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

Federal University of São Paulo1 site in 1 country30 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Change in Photographic Evaluation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

5% 5-fluoruracil cream

Active Comparator

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

Intervention: 5-fluoruracil (Procedure)

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

Intervention: 5-fluoruracil (Procedure)

Outcomes

Primary Outcomes

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

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 Outcomes

  • 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)

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other

Study Sites (1)

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