CClinicalTrials.gg
CompletedNCT00293163Updated Mar 5, 2015

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 interventional study of Hylaform, Hylaform Plus (hylan B gel) in Facial Wrinkles, sponsored by Genzyme, a Sanofi Company. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-05.

Sponsored by Genzyme, a Sanofi Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Facial Wrinkles
03

In context

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion criteria

Exclusion Criteria:

  • pregnant/lactating women
  • patients who previously received permanent facial implants or using over-the-counter products
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants

Interventions

  • DeviceHylaform, Hylaform Plus (hylan B gel)
06

What researchers measure

Primary outcomes

  1. no difference in keloid and scar formation

  2. pigmentation disorders

  3. hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique

07

Study locations

3 sites
  • Vitiligo & Pigmentation Institute of Southern California
    Los Angeles, California 90036, United States
  • Grekin Skin Institute
    Warren, Michigan 48088, United States
  • Society Hill Dermatology
    Philadelphia, Pennsylvania 19107, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00293163
Lead sponsor
Genzyme, a Sanofi Company
Collaborators
Inamed Aesthetics
First posted
Feb 17, 2006
Start date
Feb 2006
Completion
Oct 2006
Last update
Mar 5, 2015

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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