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OpenTrials
Active, Not Recruiting

NCT Number: NCT07280637

Regenarative Treatment of Periocular Wrinkles With PDRN

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cavalca & Cortelli private research center

Taubaté, São Paulo, 12010700, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Glogau II and III
  • Fitzpatrick II and III

Exclusion criteria

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

Treatment and study plan

Intradermal injection

Procedure

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

Micro needling

Procedure

three periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide

Primary outcomes

  1. severity of periocular wrinkles

    Time frame: baseline vs. 30 days

    changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs

Secondary outcomes

  1. Glogau's facial photoaging scale

    Time frame: Baseline vs. 6 months

    Changes in Glogau scores (ranging 1 - 4); higher scores indicate worse outcome

  2. LINE-1

    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

  3. LINE-1

    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

  4. severity of periocular wrinkles

    Time frame: Baseline vs. 6 months

    changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs

Sponsors and collaborators

Lead sponsor

University of Taubate

Other

Collaborators

  • Cavalca & Cortelli private research center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.