PhotoagingNCT06195605
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
A study testing Restylane-L in people with Photoaging, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Photoaging
- What is being tested?
- Restylane-L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to Feb 2027
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must understand and sign the informed consent prior to participation
- Subjects must be in generally good health
- Subjects must be able and willing to comply with the requirements of the protocol
Who cannot join
- Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
- Individuals with bleeding disorders
- Tend to heal poorly or form very thick scars called keloids
- Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- Individuals with active inflammation or infection of the skin, including active herpes infection.
- Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
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- History of allergies to gram positive bacterial proteins
- Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- Have an active inflammation or infection of the skin near the site of injection
- Are taking any medications that suppress your immune system
- Have severe allergies to medications or other things that we believe might make participation unsafe for you
- Have a history of connective tissue diseases, such as:
- rheumatoid arthritis
- scleroderma
- polymyositis/dermatomyositis
- systemic lupus erythematosus (SLE)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.
- Conditions
- Photoaging
- Being tested
- Restylane-L, Vehicle
- Keywords
- Extracellular matrix, Hyaluronic acid, dermal filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane-LDevice
Using a small gauge metal hub needle, two injections of CL-HA dermal filler (Restylane-L) will be performed, each into a small area (approximately 2 x 2 cm) of the mid-dermis of a forearm of a subject. Each injection will be 0.5 cc in volume, and will be approximately 2 cm apart from each other
VehicleDevice
Two injections of vehicle will be performed in the same manner as Restylane-L and in the same forearm, totaling 4 injections. A plastic template will be used to track the location of the injections, relative to landmarks on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Photodamaged skin | Experimental | Not described Receives: Device: Restylane-L; Device: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin
Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition.
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start9 May 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Gary Fisher, University of Michigan
- Investigators
- Gary Fisher, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195605
- Sponsor's protocol ID
- HUM00230920
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
- ClinicalTrials.gov ID
- NCT06195605
- Acronym / sponsor ID
- HUM00230920
- Conditions
- Photoaging
- Keywords
- Extracellular matrix, Hyaluronic acid, dermal filler
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 9 May 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Jan 2024 (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 the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodamaged skin | Experimental | Device: Restylane-L, Device: Vehicle |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must understand and sign the informed consent prior to participation
- Subjects must be in generally good health
- Subjects must be able and willing to comply with the requirements of the protocol
Key exclusion criteria (16 listed)
- Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
- Individuals with bleeding disorders
- Tend to heal poorly or form very thick scars called keloids
- Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- Individuals with active inflammation or infection of the skin, including active herpes infection.
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 |
|---|---|---|
| Restylane-LUsing a small gauge metal hub needle, two injections of CL-HA dermal filler (Restylane-L) will be performed, each into a small area (approximately 2 x 2 cm) of the mid-dermis of a forearm of a subject. Each injection will be 0.5 cc in volume, and will be approximately 2 cm apart from each other | Device | Photodamaged skin |
| VehicleTwo injections of vehicle will be performed in the same manner as Restylane-L and in the same forearm, totaling 4 injections. A plastic template will be used to track the location of the injections, relative to landmarks on the skin. | Device | Photodamaged skin |
Primary outcome
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin
Time frame: Approximately 4 weeks
Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition.
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 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Gary Fisher principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane-L in people with Photoaging, run by University of Michigan 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 3 inclusion and 16 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 17 Aug 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?
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?
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin (time frame: Approximately 4 weeks). 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 17 Aug 2026.