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NCT07473661 · ClinicalTrials.gov registry record · NA
Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix
A NA study of Healthy Adult, sponsored by SerenaGroup.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07473661: Recruiting NA study of Healthy Adult, sponsored by SerenaGroup.
NCT07473661 is a NA study of Healthy Adult that is actively recruiting participants, run by SerenaGroup. The registered enrollment target is 20 participants, below the 72-participant average among 8 other Healthy Adult trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07473661, a NA study of Healthy Adult, is actively recruiting participants, sponsored by SerenaGroup.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4).
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 |
What NCT07473661 shows while recruiting
NCT07473661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 72-participant average among 8 other Healthy Adult trials with a reported enrollment target (72% lower).
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.
NCT07473661 reports a single indexed study location in Pennsylvania.
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.
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).
Who is sponsoring clinical trial NCT07473661?
This trial is sponsored by SerenaGroup, which has 10 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07473661's enrollment target sits among peer trials
20 7th of 8 higher than 2 of 8 other Healthy Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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