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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293163

Enrollment

120

Registered

2006-02-17

Start date

2006-02-28

Completion date

2006-10-31

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Wrinkles

Brief 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

DEVICEHylaform, Hylaform Plus (hylan B gel)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
no difference in keloid and scar formation	—
pigmentation disorders	—
hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026