Regenarative Treatment of Periocular Wrinkles With PDRN

NCT07280637 | Recruiting DMC

• 1 other identifier: CAAE77259324.6.0000.5501
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Wrinklings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Glogau's facial photoaging scale

  Baseline vs. 6 months

• LINE-1

  baseline vs. 30 days

• LINE-1

  baseline vs. 6 months

• severity of periocular wrinkles

  Baseline vs. 6 months

Study Arms (2)

Intradermotherapy

EXPERIMENTAL

polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection

Procedure: Intradermal injection

Microneedling

ACTIVE COMPARATOR

polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling

Procedure: Micro needling

Interventions

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

Also known as: Intradermotherapy

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

Microneedling

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glogau II and III
• Fitzpatrick II and III

You may not qualify if:

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

Sponsors & Collaborators

• University of Taubate: lead
• Cavalca & Cortelli private research center: collaborator

Study Sites (1)

Cavalca & Cortelli private research center

Taubaté, São Paulo, 12010700, Brazil

RECRUITING

MeSH Terms

Interventions

Injections, Intradermal

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jose R Cortelli, doctorate

  Univeristy of Taubate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila a C Cortelli, Doctorate

CONTACT

+55(12)996016115; cortellisheila@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistics
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Model Details: Randomized, single-blind, parallel groups

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 12, 2025
• Study Start: November 30, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)