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

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05720000
• Other study ID #: PCG
• Status: Completed
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: August 23, 2023

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 23, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Skin Wrinkling

Intervention

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.

Locations

Country	Name	City	State
Brazil	Clinic Cursos	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema assessed by Ultrasound	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	Before treatment (day 0)
Primary	Edema assessed by Ultrasound	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	24 hours after PDO thread application (day 1)
Secondary	dermis thickness	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	Before treatment (day 0)
Secondary	dermis thickness	Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.	day 90
Secondary	PDO thread hydrolysis	Ultrasound identification of presence or absence of the thread	day 180
Secondary	Photos	Image registration of the region treated	Before treatment (day 0)
Secondary	Photos	Image registration of the region treated	24 hours after PDO thread application (day 1)
Secondary	Photos	Image registration of the region treated	day 90
Secondary	Photos	Image registration of the region treated	day 180