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

NCT04824612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Keloid
  • Cicatrix

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.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Raquel AM Ferrari, Phd · Nove de Julho University (Uninove)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2023-10-01
Completion
2023-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824612 on ClinicalTrials.gov