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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Wrinkling, Edema

Intervention / Treatment
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* Device: Photobiomodulation
* Procedure: PDO thread


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 24 hours after PDO thread application (day 1) | 
| dermis thickness | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | day 90 | 
| dermis thickness | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | day 180 | 
| PDO thread hydrolysis | Ultrasound identification of presence or absence of the thread | 24 hours after PDO thread application (day 1) | 
| PDO thread hydrolysis | Ultrasound identification of presence or absence of the thread | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polydioxanone thread, LED, photobiomodulation (PBM), Glabellar line