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NCT00941317 · ClinicalTrials.gov registry record · Phase 1

Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis

A Phase 1 study of Onychomycosis, sponsored by Galderma R&D.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT00941317 is a Phase 1 study of Onychomycosis that has completed, run by Galderma R&D. The registered enrollment target is 25 participants, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00941317, a Phase 1 study of Onychomycosis, has completed, sponsored by Galderma R&D.

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

Study Summary

Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affected parts of the nail. The aim of this study is to determine the optimal drilling condition that could be used in future studies of this device in combination with topical treatment for onychomycosis.

Conditions Studied

Interventions

  • DEVICE Pathformer (micro-drilling device)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-07
Est. Completion 2009-09
Phase Phase 1

Sponsor

Galderma R&D

158 total trials

What the Registry Record Tells You About NCT00941317

The ClinicalTrials.gov registry entry for NCT00941317 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 92-participant average among 11 other Onychomycosis trials with a reported enrollment target (73% lower). The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Onychomycosis appearing as the primary indexed condition, and to 1 intervention - of which Pathformer (micro-drilling device) is the first listed.

NCT00941317 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00941317 about?

NCT00941317 is a clinical study titled "Single-blind Evaluation of Device to Nail Micro-drilling in Onychomycosis". Based on manufacturer testing, no major difference in drilling condition is expected in this study compared to the drilling conditions previously established. However clinical testing is needed to establish optimal drilling conditions to be used for further development in both unaffected and affecte...

What is the current status of trial NCT00941317?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2009-07. Estimated completion is 2009-09.

What conditions does trial NCT00941317 study?

This clinical trial studies the following conditions: Onychomycosis.

What interventions are being tested in trial NCT00941317?

The interventions under investigation include: Pathformer (micro-drilling device) (DEVICE).

Who is sponsoring clinical trial NCT00941317?

This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00941317 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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