Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery.

NACompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 30, 2021

Primary Completion Date

October 1, 2023

Study Completion Date

November 30, 2023

Conditions
KeloidCicatrix
Interventions
DEVICE

Photobiomodulation with blue led

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. blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J).

DRUG

Triamcinolone Hexacetonide

intralesional injection of 20 mg/ml. 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.

DEVICE

Sham LED

A blue LED without power and biologic effect.

Trial Locations (1)

01.504-001

Nove de Julho University (Uninove), São Paulo

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT04824612 - Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery. | Biotech Hunter | Biotech Hunter