PDRN treatment for under-eye (periocular) wrinkles

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

This trial tests two ways of applying a gel with 0.2% PDRN, 2% hyaluronic acid, and 0.1% niacinamide to see if they improve periocular wrinkles in adults with moderate photoaging.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: University of Taubate (Academic / other)
• Locations: 1 site (Taubaté, São Paulo)
• Trial ID: NCT07280637 on ClinicalTrials.gov

What this trial studies

This randomized trial compares intradermal needling versus microneedling as delivery methods for a formulation containing 0.2% PDRN, 2% hyaluronic acid, and 0.1% niacinamide. Twenty-four participants with moderate periocular photoaging will be randomized 1:1 and receive three treatment sessions spaced 30 days apart, with 1 mL applied per session. Outcomes include standardized 3D Vectra imaging of periocular wrinkle severity, Glogau photoaging scale, epigenetic markers, skin-quality parameters, pigmentation, and inflammatory response measured at baseline and at 30 and 180 days. Statistical comparisons will be made within and between groups using a 5% significance level.

Who should consider this trial

Good fit: Adults with moderate periocular photoaging (Glogau II–III) and Fitzpatrick skin types II–III who are non-smokers, not pregnant, without immune disease, and who have not had facial aesthetic treatments in the past six months.

Not a fit: People with mild or very advanced photoaging (Glogau I or IV), Fitzpatrick types outside II–III, current smokers, those with immune diseases, pregnant individuals, or anyone who had facial aesthetic treatments in the past six months are excluded and may not benefit from these procedures.

Why it matters

Potential benefit: If successful, the treatment could reduce under-eye wrinkle depth and improve skin texture and hydration using minimally invasive procedures.

How similar studies have performed: Prior small studies and clinical reports suggest PDRN and microneedling can improve skin quality and hydration, but direct head-to-head comparisons of intradermal needling versus microneedling are limited.

Eligibility criteria

Inclusion Criteria:

* Glogau II and III
* Fitzpatrick II and III

Exclusion Criteria:

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

Where this trial is running

Taubaté, São Paulo

• Cavalca & Cortelli private research center — Taubaté, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Jose R Cortelli, doctorate — Univeristy of Taubate
• Study coordinator: Sheila a C Cortelli, Doctorate

Conditions Skin Wrinklings