Intralesional 5‑fluorouracil to reduce hypertrophic scars around the eyes
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
PHASE4 · Instituto de Oftalmología Fundación Conde de Valenciana · NCT07397520
This trial will try injecting small weekly doses of 5‑fluorouracil into raised periocular scars in adults to see if the scars shrink and look better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana (other) |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT07397520 on ClinicalTrials.gov |
What this trial studies
Adults with hypertrophic periocular scars from trauma or cosmetic surgery will have baseline photographs and measurements recorded, then receive 0.5 mL of intralesional 5‑fluorouracil (25 mg/mL) once weekly for four weeks. Clinical photographs and scar dimensions will be captured at each follow-up visit to document change. Participants with active local infection, active inflammatory ocular/dermatologic disease, pregnancy, breastfeeding, or known 5‑FU allergy are excluded. Safety and any local or systemic adverse reactions will be monitored throughout the treatment period.
Who should consider this trial
Good fit: Adults aged 18 or older with hypertrophic facial scars in the periocular region from trauma or cosmetic surgery who can give informed consent and attend weekly visits are ideal candidates.
Not a fit: Patients with active periocular infection, active inflammatory eye or skin disease, pregnancy or breastfeeding, known allergy to 5‑FU, or inability to complete follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, this treatment could reduce the thickness and visibility of raised scars around the eyes, improving appearance.
How similar studies have performed: Intralesional 5‑fluorouracil has been used successfully for hypertrophic and keloid scars elsewhere on the body, though specific data for periocular scars are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mexico City, Mexico City
- Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P. — Mexico City, Mexico City, Mexico (RECRUITING)
Study contacts
- Study coordinator: Diego A Alvarado Herrera MD, Medical Doctor
- Email: diegoalvarado95@hotmail.com
- Phone: +52 55 5403 1962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Facial Scarring, 5-FU, Fibrotic Scar