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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: Completed Phase 1 study of Rosacea, sponsored by Sun Pharmaceutical Industries.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
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
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01513863 record still lists
NCT01513863 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 23 other Rosacea trials with a reported enrollment target (177% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Rosacea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01513863's enrollment target sits among peer trials
602 3rd of 23 higher than 21 of 23 other Rosacea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rosacea 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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