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Completed

NCT Number: NCT03597256

Restylane Defyne for Correction of Chin Retrusion

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.

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Key information

Conditions

Chin Retrusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participated with signed and dated informed consent form.
  • Men or women aged 18 years of age or older of Chinese origin.
  • Subjects who were seeking augmentation therapy for chin retrusion.
  • GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
  • Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
  • History of severe or multiple allergies, manifested by anaphylaxis.
  • Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
  • Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
  • Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
  • Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Treatment and study plan

Restylane Defyne

Device

Intradermal injection

Primary outcomes

  1. Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)

    Time frame: At Month 6

    GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.

Secondary outcomes

  1. Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)

    Time frame: Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment

    GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases.

  2. Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator

    Time frame: At Week 4 and Months 3, and 6

    GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Jun 12, 2024

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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