Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery.
Keloid, Cicatrix
About this trial
This is an interventional treatment trial for Keloid focused on measuring keloid, photobiomodulation, corticoid
Eligibility Criteria
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.
Sites / Locations
- Nove de Julho University (Uninove)
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Sham Group
Experimental Group
intralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide (Triancil®, Apsen Farmacêutica S.A.) - two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies. Sham PBM in the preoperative and postoperative periods of keloid removal surgery: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month.
Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). Frequency: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. Intralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide: two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies.