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Completed

NCT Number: NCT05720000

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

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).

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Key information

Conditions

Skin Wrinkling Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic Cursos

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

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

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.

Primary outcomes

  1. Edema assessed by Ultrasound

    Time frame: Before treatment (day 0)

    Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

  2. Edema assessed by Ultrasound

    Time frame: 24 hours after PDO thread application (day 1)

    Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

Secondary outcomes

  1. dermis thickness

    Time frame: Before treatment (day 0)

    Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

  2. dermis thickness

    Time frame: day 90

    Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.

  3. PDO thread hydrolysis

    Time frame: day 180

    Ultrasound identification of presence or absence of the thread

  4. Photos

    Time frame: Before treatment (day 0)

    Image registration of the region treated

  5. Photos

    Time frame: 24 hours after PDO thread application (day 1)

    Image registration of the region treated

  6. Photos

    Time frame: day 90

    Image registration of the region treated

  7. Photos

    Time frame: day 180

    Image registration of the region treated

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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