Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation

U

University of Nove de Julho

Status and phase

Unknown
Phase 2

Conditions

Wrinkle

Treatments

Radiation: Photobiomodulation
Other: Placebo PRP application
Procedure: PRP application
Other: Placebo Photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04145999
Erick

Details and patient eligibility

About

Skin aging is an irreversible, slow and progressive process. It is influenced mainly by age, but also by external factors such as ultraviolet radiation, smoking, alcohol, among others. It is increasingly common to look for procedures that slow this process by limiting or hiding its effects on the skin and its appearance. Intradermal platelet-rich plasma (PRP) injection is a new modality of treatment which has possible beneficial effects on skin rejuvenation. In addition, studies have shown photobiomodulation (PBM) benefits to the skin. The purpose of this paper is to investigate the effects of combined use of intradermal PRP injection on the face and photobiomodulation for facial rejuvenation. To this end, a randomized, double-blind, controlled clinical trial will be conducted with volunteer participants who wish to improve facial aesthetics, attended at the Nove de Julho University specialty medical outpatient clinic in the city of São Paulo. Participants will be divided into three groups: one group will undergo intradermal application of PRP in association with PBM; another group will undergo intradermal application of PRP and placebo light and a third group will receive intradermal application of 0.9% saline solution (placebo) associated with PBM. Only one application of PRP or saline solution will be performed at defined points on the face. PBM sessions will be held immediately after the first application of PRP or saline solution, 3 days after the first application and weekly for the next 3 weeks. The following variables will be studied for further analysis: face moldings analyzed by optical coherence tomography; skin viscoelasticity; histological study of the dermis; evolutionary comparison of photographic images by plastic surgeons (Wrinkle Assessment Scale) and participants' satisfaction level (FACE-Q). All data will be statistically evaluated according to their distribution.

Enrollment

96 estimated patients

Sex

Female

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Menopause (at least 12 months without menstruation);
  • Healthy;
  • Skin phototype from I to IV by Fitzpatrick classification.

Exclusion criteria

  • History of photosensitivity;
  • Use of corticosteroids, anticoagulants, or any drug known to increase photosensitivity, including systemic retinoids and topical retinoic acid use for the past 6 months;
  • Carriers of any collagen-related diseases, malnutrition, anemia, immunosuppression, cancer diseases, smokers, predisposition to hypertrophic and keloid scarring, history of dermatological diseases, facial surgery, facial trauma, conditions that could affect skin condition and psychiatric diseases;
  • Patients with blood dyscrasias and thrombocytopenia;
  • Esthetic procedures on the face, such as botulinum toxin application in the last year, facial filling in the last 2 years, chemical peels, ablative laser and dermabrasion in the last year;
  • Those who do not comply with post-treatment recommendations or fail to attend a treatment session;
  • During the procedures those who present any type of complication (hematoma, allergies) will not be part of the statistical analysis, as these cases will not be in the expected pattern for these procedures. However, these data will be described and discussed, as well as possible adverse effects ,and participants will receive treatment to solve the condition.

Trial design

96 participants in 3 patient groups

PRP + PBM group
Experimental group
Description:
This group will receive both PRP application and photobiomodulation.
Treatment:
Procedure: PRP application
Radiation: Photobiomodulation
PRP + placebo PBM
Experimental group
Description:
This group will receive PRP application and placebo photobiomodulation.
Treatment:
Other: Placebo Photobiomodulation
Procedure: PRP application
PBM + placebo PRP
Experimental group
Description:
This group will receive placebo PRP application with a saline solution and active photobiomodulation.
Treatment:
Other: Placebo PRP application
Radiation: Photobiomodulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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