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).

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.

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.

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.

The sharing will begin 3 months following article publication.

Researchers who provide a methodologically sound proposal.

Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.