Facial Scarring
Conditions
Keywords
5-FU, Fibrotic Scar, Facial Scarring
Brief summary
To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.
Detailed 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.
Interventions
DRUGIntralesional administration of 5-fluorouracil
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
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intralesional administration of 5-fluorouracil will be conducted in the periocular scar. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in the size of facial hypertrophic scars | 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 |
Countries
Mexico
Outcome results
None listed