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

NCT ID: NCT05720000

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-08-23

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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

Intervention Type: 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 sham photobiomodulation (PBM)

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

Group Type: SHAM_COMPARATOR

PDO thread

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Christiane Pavani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiane Pavani, PhD

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

Clinic Cursos

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PCG

Identifier Type: -

Identifier Source: org_study_id