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NCT01139008 · ClinicalTrials.gov registry record · Phase 4
Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
A Phase 4 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT01139008: Completed Phase 4 study, sponsored by Galderma R&D.
NCT01139008 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01139008, a Phase 4 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.
Primary Outcome
Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.
Interventions
- DRUG metronidazole 1% gel
- DRUG azelaic acid 15% gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT01139008 record still lists
NCT01139008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which metronidazole 1% gel is the first listed.
NCT01139008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01139008 about?
NCT01139008 is a clinical study titled "Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin". The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.
What is the current status of trial NCT01139008?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2010-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01139008?
The interventions under investigation include: metronidazole 1% gel (DRUG), azelaic acid 15% gel (DRUG).
Who is sponsoring clinical trial NCT01139008?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01139008's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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