Restylane Defyne for Correction of Chin Retrusion

Chin Retrusion Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597256
• Other study ID #: 43CH1627
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: May 2024
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 9, 2020
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participated with signed and dated informed consent form.

2. Men or women aged 18 years of age or older of Chinese origin.

3. Subjects who were seeking augmentation therapy for chin retrusion.

4. GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.

2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.

3. History of severe or multiple allergies, manifested by anaphylaxis.

4. 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.

5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.

6. 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.

7. 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.

Related Conditions & MeSH terms

• Chin Retrusion

Intervention

Device:
• Restylane Defyne
Intradermal injection

Locations

Country	Name	City	State
China	Galderma Research Site	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	At Month 6
Secondary	Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)	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.	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
Secondary	Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator	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.	At Week 4 and Months 3, and 6