NCT05720000

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Skin Wrinkling
• Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-25
• Primary completion: 2023-02-17
• Completion: 2023-08-23
• First posted: 2023-02-09
• Last updated: 2024-04-01

Locations

1 site across 1 country: Brazil