Clinical trial NCT05720000: Use of Red Light Emitting Diode (LED) and Polydioxanone Thread in Glabellar Wrinkles
Official title: Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Wrinkling
Edema
Keywords: polydioxanone thread
LED
photobiomodulation (PBM)
Glabellar line
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Edema assessed by Ultrasound
timeFrame: Before treatment (day 0)
measure: Edema assessed by Ultrasound
timeFrame: 24 hours after PDO thread application (day 1)
Secondary outcomes:
measure: dermis thickness
timeFrame: Before treatment (day 0)
measure: dermis thickness
timeFrame: day 90
measure: PDO thread hydrolysis
timeFrame: day 180
measure: Photos
timeFrame: Before treatment (day 0)
measure: Photos
timeFrame: 24 hours after PDO thread application (day 1)
measure: Photos
timeFrame: day 90
measure: Photos
timeFrame: day 180
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinic Cursos
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Christiane Pavani, PhD
role: STUDY_DIRECTOR
References: