Injectable Filler for Facial Soft Tissue Augmentation

Panaxia Ltd218 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

218

Conditions

Wrinkles

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is over 18 years of age * Patient received Hydroxytite injection(s). Exclusion Criteria: • Patient declines to participate in the study

Outcomes

Primary Outcomes

To assess the safety of Hydroxytite (Crystalys) in subjects who received subdermal or deep-dermal injections

Adverse events or Serious adverse events, Injection site reactions.

Time frame: 6 months

Secondary Outcomes

Performance

To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline

Time frame: 6 months

Performance

To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline

Time frame: 6 months

Data from ClinicalTrials.gov

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