Cavalca & Cortelli private research center
Taubaté, São Paulo, 12010700, Brazil
NCT Number: NCT07280637
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.
This study is active but is not currently recruiting participants.
Notify Me30 year and older
All sexes
Interventional
Not applicable
Taubaté, São Paulo, 12010700, Brazil
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%.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
three periorbital intradermal injection sessions, at 30-day intervals, of polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
Other names: Intradermotherapy
three periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
Time frame: baseline vs. 30 days
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
Time frame: Baseline vs. 6 months
Changes in Glogau scores (ranging 1 - 4); higher scores indicate worse outcome
Time frame: 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
Time frame: baseline vs. 6 months
Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements
Time frame: Baseline vs. 6 months
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
University of Taubate
Other
Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.