Regenarative Treatment of Periocular Wrinkles With PDRN

University of Taubate

Status: Enrolling

Conditions: Skin Wrinklings

Treatments: Procedure: Micro needling; Procedure: Intradermal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07280637

CAAE77259324.6.0000.5501

Details and patient eligibility

About

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.

Full description

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%.

Enrollment: 25 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Glogau II and III
• Fitzpatrick II and III

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Intradermotherapy

Experimental group

Description:

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

Treatment:

Procedure: Intradermal injection

Microneedling

Active Comparator group

Description:

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

Treatment:

Procedure: Micro needling