A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288470

Enrollment

Unknown

Registered

2006-02-08

Start date

2002-06-30

Completion date

2003-08-31

Last updated

2015-03-18

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

Conditions

Facial Wrinkles

Brief summary

A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.

Interventions

DEVICEHylaform, Hylaform Plus (hylan B gel)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

30 Years to 55 Years

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 ovet-the-counter products

Design outcomes

Primary

Measure	Time frame
Non-inferiority as compared to standard of care as assigned by blinded reviewer.	—

Outcome results

None listed

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