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NCT01513863 · ClinicalTrials.gov registry record · Phase 1

A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea

A Phase 1 study of Rosacea, sponsored by Sun Pharmaceutical Industries.

Completed
Registry status
Phase 1
Development phase
602
Enrollment target
20
Study locations

NCT01513863 is a Phase 1 study of Rosacea that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 602 participants, above the 217-participant average among 23 other Rosacea trials with a reported enrollment target (177% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01513863, a Phase 1 study of Rosacea, has completed, sponsored by Sun Pharmaceutical Industries.

COMPLETED
Registry status
Phase 1
Development phase
602 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Metronidazole Topical Gel 1%
  • DRUG Metronidazole Topical Gel 1% (Metrogel)

Study Locations (20)

Florida

  • Investigator Site - Jacksonville
  • Investigator Site - Miami
  • Investigator Site - Miramar

North Carolina

  • Investigator Site - Hickory
  • Investigator Site - High Point
  • Investigator Site - Wilmington

Tennessee

  • Investigator Site - Kingsport
  • Investigator Site - Knoxville
  • Investigator Site - Nashville

California

  • Investigator Site - Long Beach
  • Investigator Site - Newport Beach

Arizona

  • Investigator Site - Phoenix

Colorado

  • Investigator Site - Denver

Illinois

  • Investigator Site - Arlington Heights

Indiana

  • Investigator Site - Plainfield

Trial Details

FieldValue
Enrollment Target 602 participants
Start Date 2011-08
Est. Completion 2012-09
Phase Phase 1

Sponsor

Sun Pharmaceutical Industries

48 total trials

What the Registry Record Tells You About NCT01513863

The ClinicalTrials.gov registry entry for NCT01513863 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 23 other Rosacea trials with a reported enrollment target (177% higher). The listed sponsor is Sun Pharmaceutical Industries, which has 48 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rosacea appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01513863 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, North Carolina, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01513863 about?

NCT01513863 is a clinical study titled "A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea". The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.

What is the current status of trial NCT01513863?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 602 participants. The study started on 2011-08. Estimated completion is 2012-09.

What conditions does trial NCT01513863 study?

This clinical trial studies the following conditions: Rosacea.

What interventions are being tested in trial NCT01513863?

The interventions under investigation include: Placebo (DRUG), Metronidazole Topical Gel 1% (DRUG), Metronidazole Topical Gel 1% (Metrogel) (DRUG).

Who is sponsoring clinical trial NCT01513863?

This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01513863 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.