Clinical trial NCT04145999: Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation
Official title: Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation: Controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wrinkle
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 96
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Photographic Analysis
timeFrame: Baseline, 3 months and 6 months after treatment.
Secondary outcomes:
measure: Change in Optical Coherence Tomography (OCT) Analysis
timeFrame: Baseline, 3 months and 6 months after treatment.
measure: Change in Skin Viscoelasticity
timeFrame: Baseline and 3 months after treatment.
measure: Change in Histological Analysis
timeFrame: Baseline and 6 months after treatment.
measure: Change of Satisfaction with Facial Appearance
timeFrame: Baseline, 3 months and 6 months after treatment.
Other outcomes:
Locations:
Study officials:
References: