Regenarative Treatment of Periocular Wrinkles With PDRN
NCT ID: NCT07280637
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-11-30
2026-08-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intradermotherapy
polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection
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
Microneedling
polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick II and III
Exclusion Criteria
* immune diseases
* tabagism
* aesthetics facial treatment in the past 6 months
30 Years
ALL
Yes
Sponsors
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Cavalca & Cortelli private research center
UNKNOWN
University of Taubate
OTHER
Responsible Party
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Jose Roberto Cortelli
Titular Professor
Principal Investigators
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Jose R Cortelli, doctorate
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Taubate
Locations
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Cavalca & Cortelli private research center
Taubaté, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Sheila C. Cortelli, Doctorate
Role: primary
Other Identifiers
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CAAE77259324.6.0000.5501
Identifier Type: -
Identifier Source: org_study_id