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OpenTrials
Completed

NCT Number: NCT07397520

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

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

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.

Mexico City, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Intralesional administration of 5-fluorouracil

Drug

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

Primary outcomes

  1. Reduction in the size of facial hypertrophic scars

    Time frame: From enrollment to the end of treatment at 4 weeks

    To objectively assess baseline status and subsequent changes in facial skin, the validated photometric visual scale from Manchester, designed for evaluating scar quality, will be employed. This scale assesses six skin parameters, including coloration, contour, distortion, texture, and brightness, assigning values from 1 to 4, where 1 represents the most favorable characteristic and 4 the least desirable

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Acronym: AI5FMHFSPRFSOE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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