Cosmetic EffectNCT07620158
Proof of Concept Study to Isolate Cosmetic Improvement of Skin Using the Vitro Biopharma Secretome/Exosome Serum
A study testing Secretome/Exosome Serum in people with Cosmetic Effect, run by Vitro Biopharma Inc. at 1 site in United States.
Trial summary
The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Effect
- What is being tested?
- Secretome/Exosome Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 30 Jan 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects over 30 years of age
- Non-smoker
- Fitzpatrick scale II-IV
- Mild to moderate skin wrinkles or fine lines around the eyes (periorbital) and/or radial cheek
- Subject agrees to maintain their weight (i.e. within 5%) by not making any major changes in diet of lifestyle during study
- Able to provide written informed consent, understand and willing to comply with study related procedures and follow-up
- Willing to undergo facial microneedling treatment
- Willing to sign photo release (For study purposes and potential publication)
Who cannot join
- Prior trauma, surgical procedure or invasive cosmetic procedure in the area of intended treatment
- Fat reduction/removal procedure in or around the area of intended treatment up to 1 year prior to enrollment
- Cosmetic injections into the area of intended treatment including botulinum toxin injections up to 6 months prior or filler injections up to 1 year prior to enrollment
- Ablative or non-ablative dermal resurfacing procedures within 6 months of screening
- Skin tightening procedures on the face within the past 3 months
- Currently using prescription facial wrinkle therapies
Show all 30Show fewer
- History of bleeding disorder, or is taking any medication that may increase risk of bruising
- Dermatological conditions in the location of the treatment sites that may interfere with treatment
- Subject has an active infection
- Subject has a known metal allergy
- Pre-existing scars, tattoos, birthmarks or other physical features in the area of treatment that may confound the outcome in the investigators opinion
- Active implanted device such as pacemaker, defibrillator, drug delivery system
- Pregnant or intending to become pregnant
- Lactating or has been lactating in the last 6 months
- History of coagulopathy, or taking anticoagulants
- Taking daily oral aspirin
- Immunocompromised or immunosuppressed
- Active, chronic or recurrent infection
- Hypersensitivity to analgesic agents
- History of keloid scar formation
- Chronic disease such as diabetes, hepatitis, etc.
- Oral corticosteroids or topical steroids in the treatment area
- Prescription or over the counter (OTC) medication or cosmetics applied to treatment area containing: retinoids, glycol acid, salicylic acid or any other remedies that might affect the healing process.
- Co-morbid condition that could limit ability to participate in the study or comply with follow-up requirements
- Untreated drug and/or alcohol abuse
- Unable or unwilling to comply with the study requirements
- Enrolled in another clinical study or taking any unknown or not Food and Drug Administration (FDA) approved medications
- Any other condition or presentation that in the opinion of the Investigator might exclude the subject
- Intends to begin any new skin medications in the treatment areas
- Intends to change their daily skincare routine before or during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Skincare Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Proof of Concept Split-Face Single-Blind Study to Assess the Cosmetic Appearance of Skin on Subjects Using the Vitro Biopharma Secretome/Exosome Serum
The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure.
- Conditions
- Cosmetic Effect
- Being tested
- Secretome/Exosome Serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretome/Exosome SerumOther
The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs
| Study group | Role | What they receive |
|---|---|---|
| Intervention v Control | Experimental | Not described Receives: Other: Secretome/Exosome Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
Adverse events related to the procedure (microneedling with or without Vitro Biopharma Exosome Serum) will be assessed at each in-person follow-up visit using the Clinical Safety Assessment (Protocol Appendix D). Physician-assessed events include erythema, edema, and scabbing/peeling/dry skin. Subject-reported events include pain, pruritis, paresthesia, and discomfort. Each event will be recorded as present or absent with severity graded as Mild, Moderate, or Severe. Number of participants with each event by severity grade will be reported for each treatment side.
Measured: Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)
Secondary outcomes (4)
Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
For each anticipated microneedling-related event (erythema, edema, scabbing/peeling/dry skin, pain, pruritis, paresthesia, discomfort) defined in Protocol Appendix D, the number of participants reporting the event on the intervention (Exosome Serum) side will be compared to the number reporting the event on the control (no Exosome Serum) side at matched post-procedure time points.
Measured: Post-procedure Days 1, 7, 21, and 45 on each treatment side (study Days 1, 7, 21, 45 for control; study Days 46, 52, 66, 90 for intervention)
Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Score by Blinded Evaluator
Aesthetic improvement of each treatment area relative to baseline images will be rated by a blinded evaluator using the 5-point GAIS (1 = Exceptional Improvement, 2 = Very Improved, 3 = Improved, 4 = Unaltered, 5 = Worsened). Mean GAIS score will be reported per treatment side at each assessment, and the difference between intervention and control sides will be reported.
Measured: Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment
Change from Baseline in Transepidermal Water Loss (TEWL)
TEWL will be measured at each treatment area using a topical probe with temperature and relative humidity sensors, reported in g/m²/h. Mean change from baseline at each post-procedure time point and the difference between intervention and control sides will be reported.
Measured: Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
Change from Baseline in Subject-Reported Clinical Global Impression-Improvement (CGI-I) Score
At each follow-up visit, subjects will rate overall appearance of each treatment area compared to before the procedure using the CGI-I (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse), per Protocol Appendix F. Mean score per side at each time point and the between-side difference will be reported.
Measured: Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start17 Apr 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic EffectStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitro Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620158
- Sponsor's protocol ID
- Vitro Biopharma 001 (VB001)
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only the individual participant data (IPD) used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Split-Face Single-Blind Study to Assess the Cosmetic Appearance of Skin on Subjects Using the Vitro Biopharma Secretome/Exosome Serum
- ClinicalTrials.gov ID
- NCT07620158
- Acronym / sponsor ID
- Vitro Biopharma 001 (VB001)
- Conditions
- Cosmetic Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vitro Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 2 Jun 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.
The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention v Control | Experimental | Other: Secretome/Exosome Serum |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects over 30 years of age
- Non-smoker
- Fitzpatrick scale II-IV
- Mild to moderate skin wrinkles or fine lines around the eyes (periorbital) and/or radial cheek
- Subject agrees to maintain their weight (i.e. within 5%) by not making any major changes in diet of lifestyle during study
Key exclusion criteria (30 listed)
- Prior trauma, surgical procedure or invasive cosmetic procedure in the area of intended treatment
- Fat reduction/removal procedure in or around the area of intended treatment up to 1 year prior to enrollment
- Cosmetic injections into the area of intended treatment including botulinum toxin injections up to 6 months prior or filler injections up to 1 year prior to enrollment
- Ablative or non-ablative dermal resurfacing procedures within 6 months of screening
- Skin tightening procedures on the face within the past 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 |
|---|---|---|
| Secretome/Exosome SerumThe Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs | Other | Intervention v Control |
Primary outcome
Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
Time frame: Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)
Adverse events related to the procedure (microneedling with or without Vitro Biopharma Exosome Serum) will be assessed at each in-person follow-up visit using the Clinical Safety Assessment (Protocol Appendix D). Physician-assessed events include erythema, edema, and scabbing/peeling/dry skin. Subject-reported events include pain, pruritis, paresthesia, and discomfort. Each event will be recorded as present or absent with severity graded as Mild, Moderate, or Severe. Number of participants with each event by severity grade will be reported for each treatment side.
4 secondary outcomes
Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
Time frame: Post-procedure Days 1, 7, 21, and 45 on each treatment side (study Days 1, 7, 21, 45 for control; study Days 46, 52, 66, 90 for intervention)
Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Score by Blinded Evaluator
Time frame: Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment
Change from Baseline in Transepidermal Water Loss (TEWL)
Time frame: Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
Change from Baseline in Subject-Reported Clinical Global Impression-Improvement (CGI-I) Score
Time frame: Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Only the individual participant data (IPD) used in the results publication will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secretome/Exosome Serum in people with Cosmetic Effect, run by Vitro Biopharma 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 8 inclusion and 30 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 2 Jun 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?
Number of Participants with Procedure-Related Adverse Events by Symptom and Severity (time frame: Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)). 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 2 Jun 2026.