Skin WrinklingsNCT07280637
Regenarative Treatment of Periocular Wrinkles With PDRN
A study testing Intradermal injection and Micro needling in people with Skin Wrinklings, run by University of Taubate at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinklings
- What is being tested?
- Intradermal injection and Micro needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Glogau II and III
- Fitzpatrick II and III
Who cannot join
- Pregnancy
- immune diseases
- tabagism
- aesthetics facial treatment in the past 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cavalca & Cortelli private research center
Taubaté, São Paulo, 12010700
About this study
Official title: Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"
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.
Read the detailed 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%.
- Conditions
- Skin Wrinklings
- Being tested
- Intradermal injection, Micro needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionProcedure or surgery
Also called Intradermotherapy
three periorbital intradermal injection sessions, at 30-day intervals, of polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
Micro needlingProcedure or surgery
three periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide
| Study group | Role | What they receive |
|---|---|---|
| Intradermotherapy | Experimental | polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection Receives: Procedure: Intradermal injection |
| Microneedling | Active comparator | polydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling Receives: Procedure: Micro needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of periocular wrinkles
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
Measured: baseline vs. 30 days
Secondary outcomes (4)
Glogau's facial photoaging scale
Changes in Glogau scores (ranging 1 - 4); higher scores indicate worse outcome
Measured: 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
Measured: 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
Measured: baseline vs. 6 months
severity of periocular wrinkles
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
Measured: Baseline vs. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 Nov 2025
- Primary completion30 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WrinklingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Collaborators
- Cavalca & Cortelli private research center
- Responsible party
- Principal investigator, Jose Roberto Cortelli, University of Taubate
- Investigators
- Jose R Cortelli, doctorate, Principal investigator, Univeristy of Taubate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280637
- Sponsor's protocol ID
- CAAE77259324.6.0000.5501
- Status last verified
- May 2026
- First submitted
- 27 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only group and codified data will be shared with study staff.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Periocular Wrinkles With the Active Ingredients PDRN, Hyaluronic Acid and Niacinamide, Applied by Needling or Microneedling: Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07280637
- Acronym / sponsor ID
- CAAE77259324.6.0000.5501
- Conditions
- Skin Wrinklings
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Collaborators
- Cavalca & Cortelli private research center
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, parallel groups
| Arm | Type | Receives |
|---|---|---|
| Intradermotherapy | Experimental | Procedure: Intradermal injectionpolydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by intradermal injection |
| Microneedling | Active comparator | Procedure: Micro needlingpolydeoxyribonucleotides (PDRN) 0.5% PDRN combined with 2% hyaluronic acid and 0.1% niacinamide delivered by micro needling |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glogau II and III
- Fitzpatrick II and III
Key exclusion criteria (4 listed)
- Pregnancy
- immune diseases
- tabagism
- aesthetics facial treatment in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injectionAlso: Intradermotherapythree periorbital intradermal injection sessions, at 30-day intervals, of polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide | Procedure or surgery | Intradermotherapy |
| Micro needlingthree periorbital micro needling sessions, at 30-day intervals, with polydeoxyribonucleotides (PDRN) 0.5% combined with 2% hyaluronic acid and 0.1% niacinamide | Procedure or surgery | Microneedling |
Primary outcome
severity of periocular wrinkles
Time frame: baseline vs. 30 days
changes in the severity (0-100%) of periocular wrinkles measured in 3-dimensional (3D) facial photographs
4 secondary outcomes
Glogau's facial photoaging scale
Time frame: Baseline vs. 6 months
LINE-1
Time frame: baseline vs. 30 days
LINE-1
Time frame: baseline vs. 6 months
severity of periocular wrinkles
Time frame: Baseline vs. 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Only group and codified data will be shared with study staff.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Cortelli, doctorate principal investigator
Univeristy of Taubate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal injection and Micro needling in people with Skin Wrinklings, run by University of Taubate at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of periocular wrinkles (time frame: baseline vs. 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.