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

Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial

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).

Study Overview

• Status: Completed
• Conditions: Edema; Skin Wrinkling
• Intervention / Treatment: Device: Photobiomodulation; Procedure: PDO thread

Detailed Description

This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of PBM with red light associated to PDO threads in individuals with static wrinkles in the glabellar region in terms of oedema, dermal thickening and PDO thread hydrolysis.

The sample will be divided into 2 groups: Group 1 will receive PDO thread and PBM with Red LED (Newskin, MMO), 150 milliwatt (mW), 2 Joule (J) per point, 4 J/cm² , 10 points per session, Group 2 will receive PDO thread and PBM sham. A total of 40 patients with glabellar wrinkle, aged 30 to 60 will be included. The treatments will consist of 9 sessions, twice a week for 30 days. The oedema and dermal thickness will be evaluated by linear ultrasound (10-14 MegaHertz (MHz), Mobisson). Photographic records will also be made.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula C Garcia; Phone Number: +5511950495795; Email: atendimento@cliniccursos.com.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Clinic Cursos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDO thread with active red LED photobiomodulation (PBM); 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; 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.; Procedure: PDO thread; 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.
Sham Comparator: PDO thread with sham photobiomodulation (PBM); Participants will receive the PDO thread and the simulated intervention with PBM using Newskin, MMO.	Procedure: PDO thread; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
dermis thickness	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	Before treatment (day 0)
dermis thickness	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	day 90
PDO thread hydrolysis	Ultrasound identification of presence or absence of the thread	day 180
Photos	Image registration of the region treated	Before treatment (day 0)
Photos	Image registration of the region treated	24 hours after PDO thread application (day 1)
Photos	Image registration of the region treated	day 90
Photos	Image registration of the region treated	day 180

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Study Director: Christiane Pavani, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: LED; polydioxanone thread; photobiomodulation (PBM); Glabellar line
• Other Study ID Numbers: PCG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices will be shared). The sharing will begin 3 months following article publication. Researchers who provide a methodologically sound proposal will have the access. Proposals should be directed to chrispavani@gmail.com. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: The sharing will begin 3 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No