Injectable Filler for Facial Soft Tissue Augmentation

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218788
• Other study ID #: Hydroxytite p100:2013
• Status: Completed
• Start date: December 2013
• Est. completion date: August 2018

Study information

• Verified date: July 2019
• Source: Panaxia Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is over 18 years of age

• Patient received Hydroxytite injection(s).

Exclusion Criteria:

• Patient declines to participate in the study

Related Conditions & MeSH terms

• Wrinkles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Panaxia Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Performance	To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline	6 months
Secondary	Performance	To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline	6 months