Injectable Filler for Facial Soft Tissue Augmentation

An Open-label, Retrospective, Postmarketing Study of Safety and Performance of Hydroxytite, a Calcium Hydroxyapatite Based Filler for Facial Soft Tissue Augmentation.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02218788

Enrollment

218

Registered

2014-08-18

Start date

2013-12-31

Completion date

2018-08-31

Last updated

2019-08-02

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

Conditions

Wrinkles

Keywords

Nasolabial folds, Marionette lines, Cheek bones, Jaw lines

Brief summary

The purpose of this study is to assess the safety and performance of Hydroxytite in all subjects who have received sub dermal or deep dermal injections.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patient is over 18 years of age * Patient received Hydroxytite injection(s).

Exclusion criteria

• Patient declines to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
To assess the safety of Hydroxytite (Crystalys) in subjects who received subdermal or deep-dermal injections	6 months	Adverse events or Serious adverse events, Injection site reactions.

Secondary

Measure	Time frame	Description
Performance	6 months	To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline

Outcome results