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

NCT04824612 | Completed

• 1 other identifier: Keloid
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

keloid; photobiomodulation; corticoid

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (4)

• keloid and remaining scar size

  These procedures will be performed in baseline (preoperatively) as well as one, three, six, and twelve months postoperatively.

• Fibroblasts analysis

  one time up to 4 weeks after preoperative treatment

• analysis of collagen

  one time up to 4 weeks after preoperative treatment

• analysis of TGF-β

  one time up to 4 weeks after preoperative treatment

Study Arms (2)

Sham Group

SHAM COMPARATOR

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.

Drug: Triamcinolone Hexacetonide; Device: Sham LED

Experimental Group

EXPERIMENTAL

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.

Device: Photobiomodulation with blue led; Drug: Triamcinolone Hexacetonide

Interventions

Photobiomodulation with blue led DEVICE

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).

Experimental Group

Triamcinolone Hexacetonide DRUG

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.

Experimental Group; Sham Group

Sham LED DEVICE

A blue LED without power and biologic effect.

Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University (Uninove)

São Paulo, 01.504-001, Brazil

Location

Related Publications (1)

• Pires JA, Bragato EF, Momolli M, Guerra MB, Neves LM, de Oliveira Bruscagnin MA, Ratto Tempestini Horliana AC, Porta Santos Fernandes K, Kalil Bussadori S, Agnelli Mesquita Ferrari R. 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 protocol study. PLoS One. 2022 Feb 15;17(2):e0263453. doi: 10.1371/journal.pone.0263453. eCollection 2022.

  PMID: 35167583 DERIVED

MeSH Terms

Conditions

Keloid; Cicatrix

Interventions

Low-Level Light Therapy; triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Raquel AM Ferrari, Phd

  Nove de Julho University (Uninove)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The evaluator, analyst, and participants will be unaware of the group to which the participants are allocated. The operator will also be unaware of whether the blue light has a biological effect or is a placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL PROFESSOR

Model Details: 58 patients will be allocated in the experimental and control groups: sham (N = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and experimental group with active PBM combined with IAC (N = 29) in the preoperative and postoperative periods of keloid removal surgery. 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, 0,4 W, 24J per point on 10 linear points, total 240J).

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: August 30, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 30, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)