Keloid scars
Conditions
Interventions
All 42 patients after randomization will be allocated in one of the two groups of this study: Group 1 (21 patients): Surgery and PDT and Group 2 (21 patients): Surgery and Placebo. The participants of
Drug
Procedure/surgery
Radiation
Q65.070
E02.186.500
HP3.073.433.101
Sponsors
Universidade Nove de Julho - UNINOVE
Universidade Nove de Julho - UNINOVE
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: This study will be conducted in men and women over 18 years with keloid.
Exclusion criteria
Exclusion criteria: Who are pregnant or lactating. Who has received any medical treatment for the keloids in the last 6 months. Who has active neoplasms Who has epilepsy. Who has diabetes. Who uses corticosteroids chronically. Who has history of allergy or hypersensitivity to the drugs (m-ALA and/or Lidocaine). Lesion dimensions that requires more complexity on the excision (like general anesthesia, reconstruction procedures) than ambulatorial surgery. Lesions larger than 10 cm². Who do not tolerate procedures with local anesthesia. Who cannot understand the study or do not sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the recurrence: For measure of the primary variable, morphometrics characteristics will be evaluated by a researcher through photos taken previously the procedures and in 1, 3, 6 and 12 months. The photos will be taken by a Canon T3 rebel, standard lens, distant 30 cm from the lesion, without zoom with standard rule and then the images will be analyzed by IMAGE-J software. Each lesion will be graded by the International Scale of Vancouver to scars. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate quality of life of the patients with keloids The participants will respond to self-assessment and quality of life questionnaires. The answers will be get from the participants trough an interview of around 15 minutes. In terms of quality of life, the questionnaire Sq 36 will be used.;Symptomatic improvement: Concerning symptoms and quality of life, an adaptation of the SCAR-Q questionnaire to the Portuguese language.;Pain presented after the surgical procedure: All participants will receive a proper form based on the analogic pain scale after the surgical procedure and must have notes about pain grade and drug administered during the 7 days after the surgical procedure. | — |
Countries
Brazil
Contacts
Public ContactEdgard da Silva Neto
Universidade Nove de Julho - UNINOVE
Outcome results
None listed