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"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Wrinklings
• Intervention / Treatment: Procedure: Intradermal injection; Procedure: Micro needling

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%.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Taubaté, São Paulo, Brazil, 12010700
      • Cavalca & Cortelli private research center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Glogau II and III
• Fitzpatrick II and III

Exclusion Criteria:

• Pregnancy
• immune diseases
• tabagism
• aesthetics facial treatment in the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intradermotherapy; polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection	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; Other Names: Intradermotherapy
Active Comparator: Microneedling; polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of periocular wrinkles	changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs	baseline vs. 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glogau's facial photoaging scale	Changes in Glogau scores (ranging 1 - 4); higher scores indicate worse outcome	Baseline vs. 6 months
LINE-1	Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements	baseline vs. 30 days
LINE-1	Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements	baseline vs. 6 months
severity of periocular wrinkles	changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs	Baseline vs. 6 months

Collaborators and Investigators

• Sponsor: University of Taubate
• Collaborators: Cavalca & Cortelli private research center
• Investigators: Principal Investigator: Jose R Cortelli, doctorate, Univeristy of Taubate

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 10, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Subcutaneous; Injections, Intradermal
• Other Study ID Numbers: CAAE77259324.6.0000.5501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only group and codified data will be shared with study staff.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No