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
Instituto de Oftalmología Fundación Conde de Valenciana
30 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.
Eligibility
Inclusion Criteria4
- Male or female participants aged ≥18 years.
- Presence of a facial scar in the periocular region secondary to trauma or facial cosmetic surgery.
- Ability and willingness to provide written informed consent.
- Signed informed consent form prior to participation.
Exclusion Criteria7
- Presence of active local infection in the periocular region.
- Active inflammatory dermatologic or ocular disorders in the treatment area.
- Known allergy or hypersensitivity to 5-fluorouracil.
- Pregnancy or breastfeeding.
- Inability to comply with follow-up visits.
- Withdrawal of consent during the study.
- Development of significant local or systemic adverse reactions during the study period.
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Interventions
For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable
Locations(1)
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NCT07397520