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NCT00293163 · ClinicalTrials.gov registry record · Phase 4

A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.

A Phase 4 study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
120
Enrollment target

NCT00293163: Completed Phase 4 study, sponsored by Genzyme, a Sanofi Company.

NCT00293163 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 120 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00293163, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
120 participants
Enrollment target

Study Summary

To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.

Interventions

  • DEVICE Hylaform, Hylaform Plus (hylan B gel)

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2006-02
Est. Completion 2006-10
Phase Phase 4
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00293163 record still lists

NCT00293163 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Hylaform, Hylaform Plus (hylan B gel) is the first listed.

NCT00293163 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00293163 about?

NCT00293163 is a clinical study titled "A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.". To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.

What is the current status of trial NCT00293163?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2006-02. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00293163?

The interventions under investigation include: Hylaform, Hylaform Plus (hylan B gel) (DEVICE).

Who is sponsoring clinical trial NCT00293163?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00293163's enrollment target sits among peer trials

120 673rd of 2000 higher than 1,289 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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Source: ClinicalTrials.gov NCT00293163, the US trial registry maintained by the National Library of Medicine. NCT00293163 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.