Keloids Cicatrix, Hypertrophic
Conditions
Interventions
Participants will be randomly allocated through a simple randomization process into intervention and control groups, totaling 100 participants, including 60 patients with hypertrophic scars or keloids
for patients with hypertrophic scars or keloids, treatments will consist of intradermal application of different medication combinations performed on opposite sides of the face of the same patient, in
Sponsors
Centro Universitário Ingá
Centro Universitário Ingá
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria comprise adult patients aged between 40 and 70 years, of both sexes, with scars ranging from 3 to 14 months in duration and measuring between 0.5 and 12 cm in maximum dimension.
Exclusion criteria
Exclusion criteria: Patients with specific contraindications to the medications, infections or skin pathologies near the scar, previous intralesional treatments, pregnancy or lactation, diabetes mellitus, hypertension, cardiovascular diseases, chronic kidney disease, a history of allergy to the study medications, or prior use of these medications for other medical conditions will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in scar and hematoma characteristics are expected, including height, pigmentation, vascularization, and malleability, as assessed using the Vancouver Scar Scale, throughout the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the reduction in lesion size, verified by measuring changes in the height, length, and width of scars and hematomas using a digital caliper, with measurable reduction in lesion dimensions being observed or expected over the follow-up period. Assess the clinical and photographic evolution of the lesions, verified through standardized photographs taken before, during, and after treatment, with progressive visual improvement of the lesions being observed or expected over time. Assess the time to clinical improvement, verified by measuring the time required to achieve satisfactory reduction of the scar or hematoma, with a defined time interval being observed or expected until significant clinical improvement is achieved. Assess patient-reported outcomes, verified through reports of symptoms such as pain, discomfort, and aesthetic satisfaction, with reduction of symptoms and increased aesthetic satisfaction being observed or expected. Assess safety and adverse effects, verified by identifying the occurrence of side effects such as pain, edema, ulceration, insomnia, or other complications related to the treatments, with a low incidence of adverse events being observed or expected | — |
Countries
BR
Contacts
Public ContactRenato Machado
Centro Universitário Ingá
Outcome results
None listed