NCT07280637

Regenarative Treatment of Periocular Wrinkles With PDRN

Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Taubate · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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%.

Conditions

• Skin Wrinklings

Interventions

Type	Name	Description
PROCEDURE	Intradermal injection	three periorbital intradermal injection sessions, at 30-day intervals, of polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
PROCEDURE	Micro needling	three periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide

Timeline

• Start date: 2025-11-30
• Primary completion: 2026-03-30
• Completion: 2026-08-30
• First posted: 2025-12-12
• Last updated: 2025-12-18

Locations

1 site across 1 country: Brazil