Use of Red Light Emitting Diode (LED) and Polydioxanone Thread in Glabellar Wrinkles
- Conditions
- Skin WrinklingEdema
- Interventions
- Procedure: PDO threadDevice: Photobiomodulation
- Registration Number
- NCT05720000
- Lead Sponsor
- University of Nove de Julho
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDO thread with sham photobiomodulation (PBM) PDO thread Participants will receive the PDO thread and the simulated intervention with PBM using Newskin, MMO. PDO thread with active red LED photobiomodulation (PBM) Photobiomodulation 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. PDO thread with active red LED photobiomodulation (PBM) PDO thread 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method dermis thickness day 90 Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
PDO thread hydrolysis day 180 Ultrasound identification of presence or absence of the thread
Photos day 180 Image registration of the region treated
Trial Locations
- Locations (1)
Clinic Cursos
🇧🇷São Paulo, SP, Brazil