Injectable Filler for Facial Soft Tissue Augmentation

Completed

• Conditions: Wrinkles

• Registration Number: NCT02218788
• Lead Sponsor: Panaxia Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2017-11
• Study Completion: 2018-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

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

Exclusion Criteria

• Patient declines to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Performance	6 months	To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline