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NCT01212809 · ClinicalTrials.gov registry record · Phase 4
Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles
A Phase 4 study of Intrinsic Aging of Skin, sponsored by Steven Fagien.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01212809: Completed Phase 4 study of Intrinsic Aging of Skin, sponsored by Steven Fagien.
NCT01212809 is a Phase 4 study of Intrinsic Aging of Skin that has completed, run by Steven Fagien. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212809, a Phase 4 study of Intrinsic Aging of Skin, has completed, sponsored by Steven Fagien.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra and CosmoDerm® 1.
Primary Outcome
Global Assessment of Improvement by Physician Evaluator, including Facial Photographs, Vertical Lip Rhytids and Radial Cheek Line Rating Scales
Conditions Studied
Interventions
- DEVICE Juvéderm Ultra
- DEVICE Cosmoderm 1
Study Locations (1)
Florida
- Steven Fagien, MD, PA - Boca Raton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01212809 record still lists
NCT01212809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Intrinsic Aging of Skin appearing as the primary indexed condition, and to 2 interventions - of which Juvéderm Ultra is the first listed.
NCT01212809 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01212809 about?
NCT01212809 is a clinical study titled "Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles". This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra an...
What is the current status of trial NCT01212809?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2010-09. Estimated completion is 2011-06.
What conditions does trial NCT01212809 study?
This clinical trial studies the following conditions: Intrinsic Aging of Skin.
What interventions are being tested in trial NCT01212809?
The interventions under investigation include: Juvéderm Ultra (DEVICE), Cosmoderm 1 (DEVICE).
Who is sponsoring clinical trial NCT01212809?
This trial is sponsored by Steven Fagien, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01212809 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01212809's enrollment target sits among peer trials
30 1552nd of 2000 higher than 368 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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