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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


Phase 3
50 Years
75 Years
Open (Enrolling)
Both
Photoaging, Actinic Keratosis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in Photographic Evaluation

Outcome 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

Outcome Time Frame:

0, 60, 180 days

Safety Issue:

No

Principal Investigator

Ediléia Bagatin, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Professor

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

Carol2011

NCT ID:

NCT01405144

Start Date:

August 2010

Completion Date:

March 2012

Related Keywords:

  • Photoaging
  • Actinic Keratosis
  • Photoaging
  • Actinic keratosis
  • 5-fluoruracil
  • Carcinogenesis
  • Keratosis
  • Keratosis, Actinic
  • Skin Diseases

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