NCT02218788

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

3.9 years

First QC Date

August 13, 2014

Last Update Submit

July 31, 2019

Conditions

Wrinkles

Keywords

Nasolabial foldsMarionette linesCheek bonesJaw lines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Performance

    6 months

  • Performance

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated with Hydroxytite, above the age of 18

You may qualify if:

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

You may not qualify if:

  • Patient declines to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2017

Study Completion

August 1, 2018

Last Updated

August 2, 2019

Record last verified: 2019-07