Skin Aging Aging
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. Participant randomization will be performed in blocks using a random sequence generated by a computer program. Experimental group
Sponsors
Universidade Federal de Ciências da Saúde de Porto Alegre
Universidade Federal de Ciências da Saúde de Porto Alegre
Eligibility
Sex/Gender
Female
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: The study will include women aged 35 to 65 years with skin phototypes I through IV on the Fitzpatrick skin phototype scale; who have a degree of photoaging of II through IV according to the Glogau Scale; report dissatisfaction with signs of facial aging such as wrinkles, fine lines, and loss of firmness; are capable of understanding all procedures, risks, and benefits of the study, and agree to read and sign the informed consent form before any research-related procedure, as well as express willingness and availability to attend all treatment sessions and scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: Participants who have active dermatological conditions such as active skin infections (bacterial, viral such as active herpes simplex, or fungal), dermatitis, psoriasis, active rosacea, inflammatory acne (grade III or IV), or any other inflammatory condition on the face; have a personal history of abnormal scarring such as hypertrophic scarring or keloid formation; are pregnant, suspect they are pregnant, are planning to become pregnant during the study, or are breastfeeding; have serious or uncontrolled systemic diseases such as uncontrolled diabetes mellitus, uncontrolled hypertension, decompensated thyroid disease, or any systemic disease that, at the researchers' discretion, may interfere with the safety or results of the study; have autoimmune and collagen diseases with cutaneous manifestations or that affect connective tissue (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis); have a diagnosis of immunodeficiency (congenital or acquired, such as HIV) or are chronically using immunosuppressant medications or systemic corticosteroids; are using specific medications such as oral isotretinoin in the last 12 months; oral anticoagulants or antiplatelet agents that cannot be safely discontinued (at the discretion of the participant's attending physician); are using any medications that may affect the bleeding or coagulation mechanism; have undergone certain previous aesthetic procedures (washout period) on the face, such as microneedling, ablative laser, medium/deep chemical peeling, or facial surgery in the last 12 months; have had dermal fillers or thread lifts in the area in the last 12 months, have had botulinum toxin injections in the area in the last 6 months, and have undergone treatments with non-ablative lasers, radiofrequency, or microfocused ultrasound in the area in the last 6 months; participants are allergic to any component of the products and materials to be used in the study, including topical anesthetics (e.g., lidocaine), metals (e.g., surgical steel needles), or the active ingredient to be used in the session, and those who are excessively exposed to the sun or refuse to adhere to sun protection during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome 1 (Type III Collagen Synthesis): An increase in serum levels of the N-terminal propeptide of type III collagen (PIIINP) is expected in the group undergoing microneedling combined with low molecular weight hyaluronic acid compared to the control group, verified by means of the enzyme-linked immunosorbent assay (ELISA) method for blood measurement of PIIINP, based on the finding of a statistically significant variation between the measurement before the procedure (T0) and twenty-eight days after the intervention (T2).;Primary Outcome 2 (Type I Collagen Synthesis): An increase in serum levels of the N-terminal propeptide of type I collagen (P1NP) is expected in the group undergoing microneedling combined with low molecular weight hyaluronic acid compared to the control group, verified by means of the electrochemiluminescence assay method (Elecsys®) for blood P1NP measurement, based on the finding of a minimum variation of ten micrograms per liter between the measurement before the procedure (T0) and twelve weeks after the intervention (T2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome 1 (Inflammatory Profile): This aims to evaluate the modulation of the systemic inflammatory response over a forty-eight-hour period, verified by means of an enzyme immunoassay method for blood measurement of interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-a), and interleukin 10 (IL-10), based on the observation of the variation in the area under the curve (AUC) of serum levels between the measurement before the procedure (T0) and forty-eight hours after the intervention (T1).;Secondary Outcome 2 (Clinical Outcomes): The aim is to verify the aesthetic improvement and satisfaction of the participants throughout the follow-up period, assessed using the Lemperle Scale for facial wrinkle classification, the Global Aesthetic Improvement Scale (GAIS) for comparative clinical evaluation, standardized photographic assessment obtained at pre-intervention (T0), forty-eight hours (T1), and twenty-eight days after the procedure (T2), and a participant satisfaction questionnaire applied at T2; local (prolonged erythema, hyperpigmentation, scarring, infection) and systemic adverse events will also be recorded at all evaluation times, with a rate of serious adverse events below five percent considered satisfactory.;Secondary Outcome 3 (Angiogenesis and Proliferative Phase): an elevation in serum levels of vascular endothelial growth factor (VEGF) is expected in the group undergoing microneedling associated with low molecular weight hyaluronic acid compared to the control group, verified by means of the enzyme immunoassay method for blood VEGF dosage, based on the finding of a statistically significant variation in serum levels measured twenty-eight days after the intervention (T2) in relation to the measurement before the procedure (T0).;Secondary Outcome 4 (Extracellular Matrix Remodeling): This study aims to evaluate the balance between degradation and synthesis of the extracellular matrix after microneedling, verified by means of an enzyme immunoassay fo | — |
Countries
BR
Contacts
Public ContactArielle de Oliveira
Universidade Federal de Ciências da Saúde de Porto Alegre
Outcome results
None listed