Skin Wrinklings
Conditions
Brief summary
This randomized clinical trial aims to compare two application techniques-needling (intradermal needling) and microneedling-for the delivery of an active-ingredient formulation containing 0.2% polynucleotides (PDRN), 2% hyaluronic acid, and 0.1% niacinamide for the treatment of periocular wrinkles related to aging.
Detailed description
Facial aging in the periocular region results from cumulative sun exposure, reduced dermal thickness, and repetitive muscular contraction, contributing to wrinkle formation and loss of skin quality. Polynucleotides (PDRN) have been reported as cellular-regeneration agents with potential to improve skin texture, hydration, and tissue recovery. The present study evaluates the clinical efficacy of a formulation composed of 0.2% PDRN, 2% hyaluronic acid, and 0.1% niacinamide, delivered by two minimally invasive techniques: needling (intradermal needling) and microneedling. Twenty four participants will be randomly allocated (1:1) into two treatment arms: needling (n=12) or microneedling (n=12). Each participant will receive three treatment sessions spaced 30 days apart, with a total volume of 1 mL applied per session. Standardized 3D facial imaging (Vectra system) will be used to assess periocular wrinkle severity (0-100%), Glogau's photoaging scale (scores 1 - 4), epigenetic markers along with skin-quality parameters, pigmentation, and inflammatory response at baseline and at 30 and 180 days following the first session. Intra-group and inter-group comparisons will be conducted using a significance level of 5%.
Interventions
PROCEDUREIntradermal injection
three periorbital intradermal injection sessions, at 30-day intervals, of polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
PROCEDUREMicro needling
three periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
Sponsors
Cavalca & Cortelli private research center
University of Taubate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
statistics
Intervention model description
Randomized, single-blind, parallel groups
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Glogau II and III * Fitzpatrick II and III
Exclusion criteria
* Pregnancy * immune diseases * tabagism * aesthetics facial treatment in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severity of periocular wrinkles | baseline vs. 30 days | changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glogau's facial photoaging scale | Baseline vs. 6 months | Changes in Glogau scores (ranging 1 - 4); higher scores indicate worse outcome |
| LINE-1 | baseline vs. 30 days | Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements |
| severity of periocular wrinkles | Baseline vs. 6 months | changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs |
Countries
Brazil
Contacts
Primary ContactSheila a C Cortelli, Doctorate
Outcome results
None listed