Chin RetrusionNCT02559908
A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw
A study testing Hyaluronic Acid Injectable Gel in people with Chin Retrusion, run by Allergan at 10 sites in 3 countries.
Trial summary
This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chin Retrusion
- What is being tested?
- Hyaluronic Acid Injectable Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 26 Feb 2015to 1 Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Has chin retrusion.
Who cannot join
- Has ever received or is planning to receive permanent facial implants during the study.
- Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
- Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
- Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
- Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study.
- Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study.
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- Has experienced trauma to the chin and jaw area within 6 months.
- Has been previously diagnosed with streptococcal disease.
- Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein.
- Has porphyria or untreated epilepsy.
- Has active autoimmune disease.
- Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion.
- Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism.
- Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
- Is on an ongoing regimen of anti-coagulation therapy.
- Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days.
- Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany6 sites
Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann
Bochum, 44803
Dermatolgie Köln am Rhein
Cologne, 50996
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, 64283
Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie
Kassel, 34121
Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster
Munich, 80333
Dermatogische Privatpraxis CentroDerm GmbH
Wuppertal, 42287
France2 sites
Cabinet medical Solferino
Paris, 75007
Centre de Chirurgie Esthetique
Toulouse, 31000
Netherlands2 sites
Kliniek Dokter Frodo Gaymans
Amsterdam, 1075
Joost Kroon Cosmetische Kliniek
Amsterdam, 1077
About this study
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw
This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.
- Conditions
- Chin Retrusion
- Being tested
- Hyaluronic Acid Injectable Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid Injectable GelDevice
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group_VYC-25L | Experimental | VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable Receives: Device: Hyaluronic Acid Injectable Gel |
| Control Group_No treatment then VYC-25L | Other | No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable. Receives: Device: Hyaluronic Acid Injectable Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Measured: Baseline, Month 3
Secondary outcomes (2)
Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
Measured: Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start26 Feb 2015
- Primary completion12 Feb 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin RetrusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Smita Chawla, Study director, Allergan, plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559908
- Sponsor's protocol ID
- V25L-001
- Status last verified
- Dec 2017
- First submitted
- 23 Sep 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw
- ClinicalTrials.gov ID
- NCT02559908
- Acronym / sponsor ID
- V25L-001
- Conditions
- Chin Retrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 25 Sep 2015 (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.
This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group_VYC-25L | Experimental | Device: Hyaluronic Acid Injectable GelVYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable |
| Control Group_No treatment then VYC-25L | Other | Device: Hyaluronic Acid Injectable GelNo treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Has chin retrusion.
Key exclusion criteria (17 listed)
- Has ever received or is planning to receive permanent facial implants during the study.
- Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
- Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
- Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
- Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid Injectable GelHyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs). | Device | Control Group_No treatment then VYC-25L, Treatment Group_VYC-25L |
Primary outcome
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Time frame: Baseline, Month 3
2 secondary outcomes
Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
Time frame: Month 3
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 13 Dec 2017.
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Aging, Chin Retrusion
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.
Smita Chawla study director
Allergan, plc
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid Injectable Gel in people with Chin Retrusion, run by Allergan at 10 sites in 3 countries.
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 1 inclusion and 17 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle (time frame: Baseline, Month 3). 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 13 Dec 2017.