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NCT01368146 · ClinicalTrials.gov registry record · Phase 1

Human Repeat Insult Patch Test of Wound Dressings

A Phase 1 study of Skin Sensitization, sponsored by Covalon Technologies.

Completed
Registry status
Phase 1
Development phase
216
Enrollment target
1
Study location

NCT01368146: Completed Phase 1 study of Skin Sensitization, sponsored by Covalon Technologies.

NCT01368146 is a Phase 1 study of Skin Sensitization that has completed, run by Covalon Technologies. The registered enrollment target is 216 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (260% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01368146, a Phase 1 study of Skin Sensitization, has completed, sponsored by Covalon Technologies.

COMPLETED
Registry status
Phase 1
Development phase
216 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

Primary Outcome

Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.

Conditions Studied

Interventions

  • DEVICE IV Clear™
  • DEVICE Tegaderm CHG™
  • DEVICE Silicone Vehicle Control Dressing

Study Locations (1)

Florida

  • Hill Top Research - St. Petersburg

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2011-03
Est. Completion 2011-04
Phase Phase 1
Covalon Technologies

4 total trials

What the finished NCT01368146 record still lists

NCT01368146 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (260% higher).

The record links to 1 condition, with Skin Sensitization appearing as the primary indexed condition, and to 3 interventions - of which IV Clear™ is the first listed.

NCT01368146 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT01368146 about?

NCT01368146 is a clinical study titled "Human Repeat Insult Patch Test of Wound Dressings". The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

What is the current status of trial NCT01368146?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 216 participants. The study started on 2011-03. Estimated completion is 2011-04.

What conditions does trial NCT01368146 study?

This clinical trial studies the following conditions: Skin Sensitization.

What interventions are being tested in trial NCT01368146?

The interventions under investigation include: IV Clear™ (DEVICE), Tegaderm CHG™ (DEVICE), Silicone Vehicle Control Dressing (DEVICE).

Who is sponsoring clinical trial NCT01368146?

This trial is sponsored by Covalon Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01368146 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01368146's enrollment target sits among peer trials

216 243rd of 2000 higher than 1,758 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01368146, the US trial registry maintained by the National Library of Medicine. NCT01368146 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.