Keloid Clinical Trial
Official title:
Effect of the Combination of Photobiomodulation Therapy and the Intralesional Administration of Corticoid in the Preoperative and Postoperative Periods of Keloid Surgery: a Randomized, Controlled, Double-blind Trial
Verified date | October 2023 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, controlled, double-blind, clinical trial will be conducted to study the evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery.
Status | Enrolling by invitation |
Enrollment | 58 |
Est. completion date | January 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age: 18 to 65 years; - Fitzpatrick skin phototype I-VI; - Keloid with no type of previous treatment; - Recurring keloid after surgical excision; - Recurring keloid after use of other therapies and at least three months without treatment. Exclusion Criteria: - Keloid in treatment; - Pregnant and lactating women; - Keloid with primary synthesis of the skin and no possibility of excision. - Contraindications for undergoing surgery (e.g.: coagulopathies, diabetes myellitus, drug allergies); - Contraindications for the use of corticosteroids; - All types of Collagenosis. |
Country | Name | City | State |
---|---|---|---|
Brazil | Nove de Julho University (Uninove) | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Nove de Julho |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | scar assessment by specialists (change in the scar of is being evaluated) | Blinded, calibrated, certified plastic surgeons will answer the Vancouver Scar Scale (VSS), which was translated into Portuguese by Santos et al. This scale focuses on four parameters:
scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 points. The VSS set a precedent for the systematic evaluation of scars, taking a semiquantitative approach to organize a collection of subjective assessments. |
Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively. | |
Primary | Quality of Life of the patients (change in quality of life is being evaluated) | The Quality of Life of Patients with Keloid and Hypertrophic Scarring questionnaire. The participants will answer the questionnaires. Answer choices are on a Likert Scale with the following choices: -5 (totally inaccurate), -3 (inaccurate), -1 (somewhat inaccurate), 1 (fairly accurate), 3 (accurate), 5 (completely accurate). | Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively. | |
Primary | patient satisfaction with the scar (change in the quality of scar is being evaluated) | The participants will also answer Part II (classification of satisfaction) of the Patient Scar Assessment Questionnaire (PSAQ) Participant answer: Very satisfied, Satisfied Dissatisfied and Very Dissatisfied. | Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively. | |
Secondary | keloid and remaining scar size | Molds will be made of the scars in light condensation silicone (Zhermack, Badia Polesine, Italy). The material will be stored in acrylic dishes and sent for analysis (optical coherence tomography) for the determination of area and volume. | These procedures will be performed in baseline (preoperatively) as well as one, three, six, and twelve months postoperatively. | |
Secondary | Fibroblasts analysis | Quantitative analysis of the fibroblasts of the keloid specimens will be performed. For such, the histological slides with the samples will be stained with hematoxylin-eosin (H.E.). This analysis is to verify the number of fibroblasts only trough visual analysis. | one time up to 4 weeks after preoperative treatment | |
Secondary | analysis of collagen | analysis of collagen fibers will also be performed using additional slices stained with Picrosirius Red. This analysis is to verify the number of fibers of collagen and your organization only trough visual analysis. | one time up to 4 weeks after preoperative treatment | |
Secondary | analysis of TGF-ß | and RNA extraction | one time up to 4 weeks after preoperative treatment |
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