Skin AgingNCT07849205
AnteAGE Exosomes and PEARL Multiplier With Microneedling for Facial Skin Quality
A study testing Mechanical microneedling, AnteAGE Exosomes and PEARL Multiplier and AnteAGE Homecare Regimen in people with Skin Aging and Skin Quality, run by Cellese Inc. at 1 site in United States.
Trial summary
This exploratory clinical study evaluated changes in facial skin quality following a series of mechanical microneedling treatments combined with topical AnteAGE Exosomes and PEARL Multiplier and a standardized AnteAGE homecare regimen. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Quality
- What is being tested?
- Mechanical microneedling, AnteAGE Exosomes and PEARL Multiplier and AnteAGE Homecare Regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged 35-65 years
- Fitzpatrick Skin Types I-VI
- In good general health and able to comply with study procedures
- Willing to abstain from non-study topical treatments and cosmetic procedures during the study
- Able to provide written informed consent
Who cannot join
- Active skin infection or inflammatory skin condition
- Systemic retinoid use within 6 months
- Corticosteroid or immunomodulator use within 4 weeks
- History of keloid formation or hypertrophic scarring
- Facial cosmetic procedures within 3 months
- Pregnant or breastfeeding
Show all 9Show fewer
- Uncontrolled medical condition or bleeding disorder
- Known allergy to any study-product ingredient
- Use of photosensitizing medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of AnteAGE Exosomes and PEARL Multiplier for Skin Quality Enhancement Using Mechanical Microneedling
This exploratory clinical study evaluated changes in facial skin quality following a series of mechanical microneedling treatments combined with topical AnteAGE Exosomes and PEARL Multiplier and a standardized AnteAGE homecare regimen. Participants underwent three microneedling treatments at approximately 4-week intervals. Outcomes included instrumental skin measurements, standardized facial imaging, investigator assessments, participant-reported outcomes, and assessment of treatment tolerability.
Read the detailed description
This was an open-label, single-arm exploratory clinical study evaluating changes in facial skin quality following mechanical microneedling combined with topical AnteAGE Exosomes and PEARL Multiplier. Participants underwent three mechanical microneedling treatments approximately 4 weeks apart. Study products were applied during and/or immediately following treatment, and participants followed a standardized homecare regimen during the study.
Assessments included standardized facial imaging, instrumental measurements of skin properties, investigator assessments, participant-reported outcomes, and safety and tolerability assessments. Participants were followed through approximately 12 weeks.
- Conditions
- Skin Aging, Skin Quality
- Being tested
- Mechanical microneedling, AnteAGE Exosomes and PEARL Multiplier, AnteAGE Homecare Regimen
- Keywords
- Skin Aging, Skin Quality, Exosomes, PDRN, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical microneedlingProcedure or surgery
Mechanical facial microneedling was performed using the Candela Exceed device on three occasions approximately 4 weeks apart.
AnteAGE Exosomes and PEARL MultiplierOther
Topical AnteAGE Exosomes and PEARL Multiplier were applied during and/or immediately following mechanical microneedling according to the study protocol.
AnteAGE Homecare RegimenOther
Participants used AnteAGE MD Serum, Accelerator and Cleanser daily, AnteAGE Face Mask weekly, and SPF 30+ daily during the study.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling With AnteAGE Exosomes and PEARL Multiplier | Experimental | Participants underwent three mechanical microneedling treatments approximately 4 weeks apart. AnteAGE Exosomes and PEARL Multiplier were applied topically during and/or immediately following microneedling. Participants followed a standardized homecare regimen consisting of AnteAGE Serum, Accelerator and Cleanser used daily, AnteAGE Face Mask used weekly, and daily SPF 30+. Receives: Procedure: Mechanical microneedling; Other: AnteAGE Exosomes and PEARL Multiplier; Other: AnteAGE Homecare Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Skin Elasticity
Skin elasticity was assessed instrumentally as average skin retraction time. Change from baseline in skin retraction time was evaluated over the 12-week study period, with decreased retraction time indicating faster skin recovery and improved elasticity.
Measured: Baseline, Week 4, Week 8, and Week 12
Change From Baseline in Coarse Facial Wrinkle Total Area
Facial wrinkles were assessed using standardized VISIA facial imaging. Coarse wrinkle total area was quantified at each assessment, and change from baseline was evaluated over the 12-week study period. Decreased coarse wrinkle total area indicates improvement in facial wrinkle appearance.
Measured: Baseline, Week 4, Week 8, and Week 12
Change From Baseline in Transepidermal Water Loss (TEWL)
Skin barrier function was assessed by measurement of transepidermal water loss (TEWL), expressed in g/m²/h. Change from baseline in TEWL was evaluated over the 12-week study period, with lower TEWL indicating reduced transepidermal water loss and improved skin barrier function.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (3)
Change From Baseline in Facial Red Features
Facial erythema-associated red features were quantified using standardized VISIA facial imaging and Red/Brown/X (RBX) analysis. Change from baseline in red feature count was evaluated over the study period, with lower counts indicating fewer erythema-associated facial features.
Measured: Baseline, Week 4, Week 8, and Week 12
Participant-Reported Improvement in Skin Quality
Participants assessed perceived changes in skin hydration, radiance, texture, fine lines and wrinkles, elasticity, hyperpigmentation/dark spots, and overall skin appearance using the study-specific participant questionnaire.
Measured: Week 12
Incidence of Treatment-Emergent Adverse Events
Number of participants experiencing treatment-emergent adverse events during the study. Adverse events were assessed for severity and relationship to the study treatment.
Measured: From first treatment through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start2 Aug 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellese Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rob Knight, PhD, Principal investigator, Cellese Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849205
- Sponsor's protocol ID
- 0003
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of AnteAGE Exosomes and PEARL Multiplier for Skin Quality Enhancement Using Mechanical Microneedling
- ClinicalTrials.gov ID
- NCT07849205
- Acronym / sponsor ID
- 0003
- Conditions
- Skin Aging, Skin Quality
- Keywords
- Skin Aging, Skin Quality, Exosomes, PDRN, Microneedling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cellese Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 30 Sep 2026 (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 exploratory clinical study evaluated changes in facial skin quality following a series of mechanical microneedling treatments combined with topical AnteAGE Exosomes and PEARL Multiplier and a standardized AnteAGE homecare regimen. Participants underwent three microneedling treatments at approximately 4-week intervals. Outcomes included instrumental skin measurements, standardized facial imaging, investigator assessments, participant-reported outcomes, and assessment of treatment tolerability.
Detailed description
This was an open-label, single-arm exploratory clinical study evaluating changes in facial skin quality following mechanical microneedling combined with topical AnteAGE Exosomes and PEARL Multiplier. Participants underwent three mechanical microneedling treatments approximately 4 weeks apart. Study products were applied during and/or immediately following treatment, and participants followed a standardized homecare regimen during the study.
Assessments included standardized facial imaging, instrumental measurements of skin properties, investigator assessments, participant-reported outcomes, and safety and tolerability assessments. Participants were followed through approximately 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microneedling With AnteAGE Exosomes and PEARL Multiplier | Experimental | Procedure: Mechanical microneedling, Other: AnteAGE Exosomes and PEARL Multiplier, Other: AnteAGE Homecare RegimenParticipants underwent three mechanical microneedling treatments approximately 4 weeks apart. AnteAGE Exosomes and PEARL Multiplier were applied topically during and/or immediately following microneedling. Participants followed a standardized homecare regimen consisting of AnteAGE Serum, Accelerator and Cleanser used daily, AnteAGE Face Mask used weekly, and daily SPF 30+. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 35-65 years
- Fitzpatrick Skin Types I-VI
- In good general health and able to comply with study procedures
- Willing to abstain from non-study topical treatments and cosmetic procedures during the study
- Able to provide written informed consent
Key exclusion criteria (9 listed)
- Active skin infection or inflammatory skin condition
- Systemic retinoid use within 6 months
- Corticosteroid or immunomodulator use within 4 weeks
- History of keloid formation or hypertrophic scarring
- Facial cosmetic procedures within 3 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 |
|---|---|---|
| Mechanical microneedlingMechanical facial microneedling was performed using the Candela Exceed device on three occasions approximately 4 weeks apart. | Procedure or surgery | Microneedling With AnteAGE Exosomes and PEARL Multiplier |
| AnteAGE Exosomes and PEARL MultiplierTopical AnteAGE Exosomes and PEARL Multiplier were applied during and/or immediately following mechanical microneedling according to the study protocol. | Other | Microneedling With AnteAGE Exosomes and PEARL Multiplier |
| AnteAGE Homecare RegimenParticipants used AnteAGE MD Serum, Accelerator and Cleanser daily, AnteAGE Face Mask weekly, and SPF 30+ daily during the study. | Other | Microneedling With AnteAGE Exosomes and PEARL Multiplier |
Primary outcome
Change from baseline in Skin Elasticity
Time frame: Baseline, Week 4, Week 8, and Week 12
Skin elasticity was assessed instrumentally as average skin retraction time. Change from baseline in skin retraction time was evaluated over the 12-week study period, with decreased retraction time indicating faster skin recovery and improved elasticity.
Change From Baseline in Coarse Facial Wrinkle Total Area
Time frame: Baseline, Week 4, Week 8, and Week 12
Facial wrinkles were assessed using standardized VISIA facial imaging. Coarse wrinkle total area was quantified at each assessment, and change from baseline was evaluated over the 12-week study period. Decreased coarse wrinkle total area indicates improvement in facial wrinkle appearance.
Change From Baseline in Transepidermal Water Loss (TEWL)
Time frame: Baseline, Week 4, Week 8, and Week 12
Skin barrier function was assessed by measurement of transepidermal water loss (TEWL), expressed in g/m²/h. Change from baseline in TEWL was evaluated over the 12-week study period, with lower TEWL indicating reduced transepidermal water loss and improved skin barrier function.
3 secondary outcomes
Change From Baseline in Facial Red Features
Time frame: Baseline, Week 4, Week 8, and Week 12
Participant-Reported Improvement in Skin Quality
Time frame: Week 12
Incidence of Treatment-Emergent Adverse Events
Time frame: From first treatment through Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be made publicly available.
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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.
Rob Knight, PhD principal investigator
Cellese Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical microneedling, AnteAGE Exosomes and PEARL Multiplier and AnteAGE Homecare Regimen in people with Skin Aging and Skin Quality, run by Cellese Inc. at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in Skin Elasticity (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 3 primary outcomes in all. 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 30 Sep 2026.