Healthy AdultSPTNCT07473674
This Study Evaluates Skin Response Following Application of a Collagen-based Material in Healthy Adult Volunteers Using a Standardized Skin Prick Test. Skin Responses Will be Assessed at Multiple Time Points Following Application, and the Study is Intended to Evaluate Dermal Safety.
A study testing Collagen Matrix Skin Prick Test Device in people with Healthy Adult, run by SerenaGroup, Inc. at 1 site in United States.
Trial summary
This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Collagen Matrix Skin Prick Test Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2026to 22 Apr 2026
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
- Age 18 to 70 years
- Able to comply with study procedures
Who cannot join
- Use of medications that may interfere with skin test responses
- Known allergy to personal care products or adhesives
- History of autoimmune disease
- History of cancer
- Uncontrolled chronic medical conditions
- History of dermatographism
Show all 9Show fewer
- Known allergy to study materials
- Known hypersensitivity to study materials
- Active dermatitis or eczema at the test site
Trial locations and contacts
1 site in 1 country.
United States1 site
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
About this study
Official title: Skin Prick Test to Evaluate Allergenic Potential of a Collagen-Based Material in Healthy Volunteers
This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.
- Conditions
- Healthy Adult
- Being tested
- Collagen Matrix Skin Prick Test Device
- Keywords
- Skin Prick Test, SPT, Collagen Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Matrix Skin Prick Test DeviceDevice
A collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants.
| Study group | Role | What they receive |
|---|---|---|
| Skin Prick Test Procedure | Experimental | Participants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers. Receives: Device: Collagen Matrix Skin Prick Test Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Prick Test Wheal Diameter
Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean wheal diameter at the test site in millimeters (mm).
Measured: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start19 Apr 2026
- Primary completion19 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473674
- Sponsor's protocol ID
- Pro00093080
- Acronym
- SPT
- Status last verified
- May 2026
- First submitted
- 4 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Prick Test to Evaluate Allergenic Potential of a Collagen-Based Material in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07473674
- Acronym / sponsor ID
- SPT / Pro00093080
- Conditions
- Healthy Adult
- Keywords
- Skin Prick Test, SPT, Collagen Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Study start
- 19 Apr 2026 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 16 Mar 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 study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Prick Test Procedure | Experimental | Device: Collagen Matrix Skin Prick Test DeviceParticipants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers
- Age 18 to 70 years
- Able to comply with study procedures
Key exclusion criteria (9 listed)
- Use of medications that may interfere with skin test responses
- Known allergy to personal care products or adhesives
- History of autoimmune disease
- History of cancer
- Uncontrolled chronic medical conditions
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 |
|---|---|---|
| Collagen Matrix Skin Prick Test DeviceA collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants. | Device | Skin Prick Test Procedure |
Primary outcome
Skin Prick Test Wheal Diameter
Time frame: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration
Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean wheal diameter at the test site in millimeters (mm).
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 15 May 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.
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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 Collagen Matrix Skin Prick Test Device in people with Healthy Adult, run by SerenaGroup, 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 3 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 15 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 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?
Skin Prick Test Wheal Diameter (time frame: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration). 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 15 May 2026.