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

Sponsor
University of Nove de Julho (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05720000
Collaborator
(none)
40
2
12.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Photobiomodulation
  • Procedure: PDO thread
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Outcomes Assessor)
Masking Description:
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
Primary Purpose:
Treatment
Official Title:
Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
Anticipated Study Start Date :
Feb 10, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Sham Comparator: PDO thread with sham photobiomodulation (PBM)

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

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.

Outcome Measures

Primary Outcome Measures

  1. Edema assessed by Ultrasound [Before treatment (day 0)]

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

  2. Edema assessed by Ultrasound [24 hours after PDO thread application (day 1)]

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

Secondary Outcome Measures

  1. dermis thickness [Before treatment (day 0)]

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

  2. dermis thickness [24 hours after PDO thread application (day 1)]

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

  3. dermis thickness [day 90]

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

  4. dermis thickness [day 180]

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

  5. PDO thread hydrolysis [24 hours after PDO thread application (day 1)]

    Ultrasound identification of presence or absence of the thread

  6. PDO thread hydrolysis [day 90]

    Ultrasound identification of presence or absence of the thread

  7. PDO thread hydrolysis [day 180]

    Ultrasound identification of presence or absence of the thread

  8. Photos [Before treatment (day 0)]

    Image registration of the region treated

  9. Photos [24 hours after PDO thread application (day 1)]

    Image registration of the region treated

  10. Photos [day 90]

    Image registration of the region treated

  11. Photos [day 180]

    Image registration of the region treated

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Nove de Julho

Investigators

  • Study Director: Christiane Pavani, PhD, University of Nove de Julho

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christiane Pavani, Clinical Professor, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT05720000
Other Study ID Numbers:
  • PCG
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 9, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christiane Pavani, Clinical Professor, University of Nove de Julho

Study Results

No Results Posted as of Feb 9, 2023