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| Name | Class |
|---|---|
| Cavalca & Cortelli private research center | UNKNOWN |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradermotherapy | Experimental | polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection |
|
| Microneedling | Active Comparator | polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose R Cortelli, doctorate | Univeristy of Taubate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cavalca & Cortelli private research center | Taubaté | São Paulo | 12010700 | Brazil |
Only group and codified data will be shared with study staff.
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| ID | Term |
|---|---|
| D007271 | Injections, Intradermal |
| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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Randomized, single-blind, parallel groups
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statistics
|
| 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 |
|
| 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 |
| D013812 |
| Therapeutics |