Edema Clinical Trial
Official title:
Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
NCT number | NCT05720000 |
Other study ID # | PCG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 25, 2023 |
Est. completion date | August 23, 2023 |
Verified date | March 2024 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | August 23, 2023 |
Est. primary completion date | February 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinic Cursos | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Nove de Julho |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Edema assessed by Ultrasound | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | Before treatment (day 0) | |
Primary | Edema assessed by Ultrasound | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | 24 hours after PDO thread application (day 1) | |
Secondary | dermis thickness | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | Before treatment (day 0) | |
Secondary | dermis thickness | Ultrasound transversal measurement from epidermis to the beginning of muscle tissue. | day 90 | |
Secondary | PDO thread hydrolysis | Ultrasound identification of presence or absence of the thread | day 180 | |
Secondary | Photos | Image registration of the region treated | Before treatment (day 0) | |
Secondary | Photos | Image registration of the region treated | 24 hours after PDO thread application (day 1) | |
Secondary | Photos | Image registration of the region treated | day 90 | |
Secondary | Photos | Image registration of the region treated | day 180 |
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