Cicatrix Wound Healing
Conditions
Interventions
This is a randomized, controlled, two-arm, single-blind clinical trial. This is a self-controlled (split-scar), longitudinal study of patients with flat surgical or traumatic scars, treated in the res
Sponsors
Centro de Pós-Graduação da Ciências Médicas de Minas Gerais – Faculdade de Ciências Médicas
Centro de Pós-Graduação da Ciências Médicas de Minas Gerais – Faculdade de Ciências Médicas
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Female patients aged between 18 and 85 years with flat surgical or traumatic scars present for more than 6 months
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women; patients who do not agree to participate in the study; patients receiving systemic corticosteroid therapy; patients with a history of connective tissue diseases; patients with severe diseases, including cardiac or respiratory decompensation, or any condition that may impair the healing process; patients with scars less than 6 months old; patients who received intralesional corticosteroid therapy within 2 months prior to study initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the difference in total POSAS Observer score between the picosecond laser-treated half and the untreated control half of the same scar, assessed by a blinded evaluator 30 days after the last treatment session (D90), using the POSAS Observer Scale. A reduction in the total score will be analyzed as an indicator of clinical improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the difference in total POSAS Patient score between the treated and untreated halves of the same scar 30 days after the last treatment session (D90), using the POSAS Patient Scale. Lower scores will indicate better patient-reported scar quality.;To evaluate differences in the POSAS Observer subscales, including vascularization, pigmentation, thickness, relief, pliability, and surface area, between treated and untreated scar halves at D90, using the POSAS Observer Scale. Reductions in subscale scores will be considered indicative of clinical improvement.;To evaluate the difference in Vancouver Scar Scale scores between treated and untreated scar halves at D90, using the Vancouver Scar Scale. Lower scores will be considered indicative of improved scar appearance and quality.;To evaluate the percentage reduction in epidermal and dermal scar thickness between treated and untreated scar halves, measured by ultrasonography 6 months after treatment completion. Greater percentage reductions in thickness will be considered indicative of improved scar remodeling.;To evaluate global aesthetic improvement through blinded photographic assessment at D90 using standardized clinical photographs. Better aesthetic ratings will be considered indicative of improved scar appearance.;To evaluate treatment tolerability using the Numerical Rating Scale (NRS) for pain immediately after the procedure. Lower pain scores will be considered indicative of better treatment tolerability. | — |
Countries
BR
Contacts
Public ContactGisele de Oliveira
Centro de Pós-Graduação da Ciências Médicas de Minas Gerais – Faculdade de Ciências Médicas
Outcome results
None listed