Injectable Filler for Facial Soft Tissue Augmentation

July 31, 2019 updated by: Panaxia Ltd

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients treated with Hydroxytite, above the age of 18

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient declines to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance
Time Frame: 6 months
To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline
6 months
Performance
Time Frame: 6 months
To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panaxia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hydroxytite p100:2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wrinkles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe