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The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years

The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years

Recruiting
18 years and older
All
Phase 4

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Overview

To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.

Description

During the initial visit, informed consent will be obtained and documented, alongside baseline photographs and measurements of the facial scar dimensions using a ruler. In the subsequent visits-second, third, fourth, and fifth-0.5 ml of intralesional 5-fluorouracil, diluted to 25 mg/ml, will be administered. Clinical photographs will be captured, and dimensions will be measured at each of these visits. A total of 0.5 ml of this solution will be injected weekly into the lesion to be treated, amounting to four doses over the course of one month.

Eligibility

Inclusion Criteria:

  • Eligible participants include male and female individuals over the age of 18 who possess a facial scar in the periocular region resulting from trauma or facial cosmetic surgery. Participants must voluntarily consent to partake in the study and have duly signed the requisite consent forms.

Exclusion Criteria:

  • Exclusion criteria encompass the presence of local infections or inflammatory disorders, an allergy to 5-fluorouracil, pregnancy or breastfeeding, and any loss of control or follow-up during the study. Additionally, individuals experiencing local or systemic adverse reactions during the research are excluded.

Study details
    Facial Scarring

NCT07397520

Instituto de Oftalmología Fundación Conde de Valenciana

26 February 2026

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