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OpenTrials
Completed

NCT Number: NCT02218788

Injectable 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.

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Key information

Conditions

Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient declines to participate in the study

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Performance

    Time frame: 6 months

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

  2. Performance

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Panaxia Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Aug 18, 2014
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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