Use of Red Light Emitting Diode (LED) and Polydioxanone Thread in Glabellar Wrinkles

NCT05720000 | Completed DMC

• 1 other identifier: PCG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Physical appearance is a factor that contributes to an individual's self-esteem. Maintaining a healthy appearance is a growing quest by the population, and aging is the main cause of discomfort for men and women. There are several aesthetic treatments capable of mitigating or delaying the effects of aging in all its layers of alteration (dermis, hypodermis, musculature and bone), and the combination of therapies has been increasingly proposed in search of a positive synergy. The dermal application of polydioxanone threads (PDO) and the low-power red LED (photobiomodulation - PBM) are individual options of resources for which there already are reports in the literature about their mechanisms of action in the proliferation of fibroblasts and collagen production. However, the joint application of these techniques requires further studies. A total of 40 patients, aged between 30 and 60 years old, phototypes I-IV in Fitzpatrick scale, Glogau 3-4, presenting static wrinkle at the glabellar region will be recruited and distributed among 2 groups: PDO thread + PBM or PDO thread + sham PBM. The treatments will consist of 30 days, with one application of PDO thread and PBM twice a week (total of 9 sessions).

Conditions

Skin Wrinkling; Edema

Keywords

polydioxanone thread; LED; photobiomodulation (PBM); Glabellar line

Outcome Measures

Primary Outcomes (2)

• Edema assessed by Ultrasound

  Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

  Before treatment (day 0)

• Edema assessed by Ultrasound

  Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

  24 hours after PDO thread application (day 1)

Secondary Outcomes (7)

• dermis thickness

  Before treatment (day 0)

• dermis thickness

  day 90

• PDO thread hydrolysis

  day 180

• Photos

  Before treatment (day 0)

• Photos

  24 hours after PDO thread application (day 1)

Study Arms (2)

PDO thread with active red LED photobiomodulation (PBM)

EXPERIMENTAL

Participants will receive the PDO thread and the intervention with PBM using red light (Newskin, MMO) 150 mW, 2J per point, 4J/cm2, 10 points, twice a week.

Device: Photobiomodulation; Procedure: PDO thread

PDO thread with sham photobiomodulation (PBM)

SHAM COMPARATOR

Participants will receive the PDO thread and the simulated intervention with PBM using Newskin, MMO.

Procedure: PDO thread

Interventions

Photobiomodulation DEVICE

Patient will receive the application of the low-power 660 nm Newskin MMO red LED in the immediate postoperative period. The application will be made punctually over the entire length of the wire, which measures 5 cm, totaling 10 application points with 1 cm of distance between them. The LED application will be repeated twice a week, with a minimum interval of 48 hours, totaling 9 laser applications over 30 days.

PDO thread with active red LED photobiomodulation (PBM)

PDO thread PROCEDURE

The participant's face will be cleaned with a 0.2% chlorhexidine solution. 0.1 ml of injectable anesthetic (2% lidocaine hydrochloride without vasoconstrictor, XYlestesin) will be administered in the skin layer at the point of incision in the glabellar region with a 30-gauge needle. A subincision will be made with a 21-gauge cannula in the glabellar ridge and then an injectable thread will be applied in the deep dermal layer below the glabellar ridge in the same direction as it.

PDO thread with active red LED photobiomodulation (PBM); PDO thread with sham photobiomodulation (PBM)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both genders
• aged between 30 and 60 years,
• Fitzpatrick skin phototype I - IV,
• levels 3 and 4 in the aging classification according to Glogau,
• presenting glabellar static wrinkles (permanent wrinkles)
• who do not have uncompensated comorbidities.

You may not qualify if:

• decompensated diabetes, lupus, HIV positive, hepatitis, high blood pressure, neurological disorders, active neoplasms,
• tendency to develop keloids,
• menopause, pregnant women,
• participants who have absorbable threads (applied less than 3 months ago) or definitive at glabella,
• who have PMMA (polymethylmethacrylate) application in any region of the face,
• who are undergoing treatment with any type of laser therapy in any areas of the body,
• participants who are undergoing aesthetic or dermatological treatment on the face,
• participants who are using anti-inflammatories and corticoids in a window of 30 days before and after the procedure,
• participants using isotretinoin in the last 6 months.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Clinic Cursos

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Edema

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Christiane Pavani, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: All participants will receive PDO thread at glabella. Immediately after application, the participants will receive the intervention related to their treatment group, according to the allocation given by randomization. After randomization, the study population will be divided into two groups (n=20 per group), which are: (1) Group A - PDO thread + PBM with red LED, (2) PDO thread + PBM sham. The treatment will be performed twice a week for 30 days, in total 9 sessions.

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: February 9, 2023
• Study Start: January 25, 2023
• Primary Completion: February 17, 2023
• Study Completion: August 23, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The sharing will begin 3 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

BR (1)