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Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix
NCT07473661 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to evaluate the skin irritation and sensitization potential of SILURCLOUD™ Fibrous Collagen Matrix in healthy adult volunteers with Fitzpatrick Skin Types I and VI. The study will also generate additional safety data to address FDA 510(k) feedback regarding representation of these skin types. The main questions it aims to answer are: Does SILURCLOUD™ Fibrous Collagen Matrix cause primary or cumulative skin irritation under maximized patch test conditions? Does SILURCLOUD™ Fibrous Collagen Matrix demonstrate allergic contact sensitization potential in human subjects? Participants will: Have patches containing the test product applied to the skin under occlusive conditions Return for repeated patch applications during the induction phase Undergo skin evaluations using standardized scoring methods Complete a challenge phase following a rest period Participate in re-challenge testing if clinically indicated
Conditions Studied
Interventions
- DEVICE SILURCLOUD Fibrous Collagen Matrix
- DRUG 0.5% Sodium Lauryl Sulfate in Distilled Water
- DRUG Glycerosaline
Study Locations (1)
Pennsylvania
- SerenaGroup Monroeville — Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-02-27 |
| Est. Completion | 2026-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07473661
The ClinicalTrials.gov registry entry for NCT07473661 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SerenaGroup, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Adult appearing as the primary indexed condition, and to 3 interventions — of which SILURCLOUD Fibrous Collagen Matrix is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07473661 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07473661 about?
NCT07473661 is a clinical study titled "Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix". The goal of this clinical trial is to evaluate the skin irritation and sensitization potential of SILURCLOUD™ Fibrous Collagen Matrix in healthy adult volunteers with Fitzpatrick Skin Types I and VI. The study will also generate additional safety data to address FDA 510(k) feedback regarding represe...
What is the current status of trial NCT07473661?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-02-27. Estimated completion is 2026-04.
What conditions does trial NCT07473661 study?
This clinical trial studies the following conditions: Healthy Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07473661?
The interventions under investigation include: SILURCLOUD Fibrous Collagen Matrix (DEVICE), 0.5% Sodium Lauryl Sulfate in Distilled Water (DRUG), Glycerosaline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07473661?
This trial is sponsored by SerenaGroup, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07473661 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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