WrinklesNCT02218788
Injectable Filler for Facial Soft Tissue Augmentation
An observational study of Wrinkles, run by Panaxia Ltd.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients treated with Hydroxytite, above the age of 18
Who may be able to join
- Patient is over 18 years of age
- Patient received Hydroxytite injection(s).
Who cannot join
- Patient declines to participate in the study
About this study
Official title: 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.
- Conditions
- Wrinkles
- Keywords
- Nasolabial folds, Marionette lines, Cheek bones, Jaw lines
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Performance
To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline
Measured: 6 months
Performance
To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panaxia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218788
- Sponsor's protocol ID
- Hydroxytite p100:2013
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2014
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Retrospective, Postmarketing Study of Safety and Performance of Hydroxytite, a Calcium Hydroxyapatite Based Filler for Facial Soft Tissue Augmentation.
- ClinicalTrials.gov ID
- NCT02218788
- Acronym / sponsor ID
- Hydroxytite p100:2013
- Conditions
- Wrinkles
- Keywords
- Nasolabial folds, Marionette lines, Cheek bones, Jaw lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Panaxia LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with Hydroxytite, above the age of 18
Key inclusion criteria (2 listed)
- Patient is over 18 years of age
- Patient received Hydroxytite injection(s).
Key exclusion criteria (1 listed)
- Patient declines to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Performance
Time frame: 6 months
Performance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles, run by Panaxia Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of Hydroxytite (Crystalys) in subjects who received subdermal or deep-dermal injections (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.