se of photodynamic therapy in keloids
Not Applicable
Recruiting
- Conditions
- Keloid scarsL91.0
- Registration Number
- RBR-5zm8cw
- Lead Sponsor
- niversidade Nove de Julho - UNINOVE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
This study will be conducted in men and women over 18 years with keloid.
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Evaluate quality of life of the patients with keloids<br>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: <br> Concerning symptoms and quality of life, an adaptation of the SCAR-Q questionnaire to the Portuguese language.;Pain presented after the surgical procedure:<br>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.