Skin WrinklingNCT05720000
Use of Red Light Emitting Diode (LED) and Polydioxanone Thread in Glabellar Wrinkles
A study testing Photobiomodulation and PDO thread in people with Skin Wrinkling and Edema, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinkling, Edema
- What is being tested?
- Photobiomodulation and PDO thread
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2023to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
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).
Read the 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
- Being tested
- Photobiomodulation, PDO thread
- Keywords
- polydioxanone thread, LED, photobiomodulation (PBM), Glabellar line
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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 threadProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PDO thread with active red LED photobiomodulation (PBM) | Experimental | 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. Receives: Device: Photobiomodulation; Procedure: PDO thread |
| PDO thread with sham photobiomodulation (PBM) | Sham comparator | Participants will receive the PDO thread and the simulated intervention with PBM using Newskin, MMO. Receives: Procedure: PDO thread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema assessed by Ultrasound
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
Measured: Before treatment (day 0)
Edema assessed by Ultrasound
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
Measured: 24 hours after PDO thread application (day 1)
Secondary outcomes (7)
dermis thickness
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
Measured: Before treatment (day 0)
dermis thickness
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
Measured: day 90
PDO thread hydrolysis
Ultrasound identification of presence or absence of the thread
Measured: day 180
Photos
Image registration of the region treated
Measured: Before treatment (day 0)
Photos
Image registration of the region treated
Measured: 24 hours after PDO thread application (day 1)
Photos
Image registration of the region treated
Measured: day 90
Photos
Image registration of the region treated
Measured: day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start25 Jan 2023
- Primary completion17 Feb 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WrinklingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Christiane Pavani, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720000
- Sponsor's protocol ID
- PCG
- Status last verified
- Mar 2024
- First submitted
- 24 Dec 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices will be shared). The sharing will begin 3 months following article publication. Researchers who provide a methodologically sound proposal will have the access. Proposals should be directed to chrispavani@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
- ClinicalTrials.gov ID
- NCT05720000
- Acronym / sponsor ID
- PCG
- Conditions
- Skin Wrinkling, Edema
- Keywords
- polydioxanone thread, LED, photobiomodulation (PBM), Glabellar line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PDO thread with active red LED photobiomodulation (PBM) | Experimental | Device: Photobiomodulation, Procedure: PDO threadParticipants 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 sham photobiomodulation (PBM) | Sham comparator | Procedure: PDO threadParticipants will receive the PDO thread and the simulated intervention with PBM using Newskin, MMO. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationPatient 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. | Device | PDO thread with active red LED photobiomodulation (PBM) |
| PDO threadThe 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. | Procedure or surgery | PDO thread with active red LED photobiomodulation (PBM), PDO thread with sham photobiomodulation (PBM) |
Primary outcome
Edema assessed by Ultrasound
Time frame: Before treatment (day 0)
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
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.
7 secondary outcomes
dermis thickness
Time frame: Before treatment (day 0)
dermis thickness
Time frame: day 90
PDO thread hydrolysis
Time frame: day 180
Photos
Time frame: Before treatment (day 0)
Photos
Time frame: 24 hours after PDO thread application (day 1)
Photos
Time frame: day 90
Photos
Time frame: day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices will be shared). The sharing will begin 3 months following article publication. Researchers who provide a methodologically sound proposal will have the access. Proposals should be directed to chrispavani@gmail.com. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Pavani, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and PDO thread in people with Skin Wrinkling and Edema, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema assessed by Ultrasound (time frame: Before treatment (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.