JUVÉDERM VOLUX® for Chin Retrusion in China

Allergan

Status and phase: Completed; Phase 3

Conditions: Chin Retrusion

Treatments: Device: JUVÉDERM VOLUX®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04559984

1868-701-008

Details and patient eligibility

About

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be at least 18 years of age at the time of signing the ICF
• Male and female
• Participants of Chinese descent
• Participants seeking improvement of chin retrusion
• Chin retrusion (G-Sn-Pog angle of < 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software
• Has moderate to severe chin retrusion on the CACRS as determined by EI 2D image evaluation
• Has a reasonable goal for aesthetic improvement in chin retrusion and is able to achieve a 1-point improvement in CACRS score with study intervention in the judgment of TI
• Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• Written informed consent from the participant has been obtained prior to any study-related procedures
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable

Exclusion criteria

• History of tendency to develop hypertrophic scarring
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein
• Active autoimmune disease
• Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention)
• Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms
• Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
• Permanent dermal filler injected below the subnasale
• Semi-permanent dermal filler or fat injected below the subnasale within 36 months before enrollment
• Temporary dermal filler injected below the subnasale within 12 months before enrollment
• Orthodontics procedures within 12 months before enrollment
• Botulinum toxin treatment in the chin area within 6 months before enrollment
• Mesotherapy or cosmetic facial procedures (eg, face-lift, brow lift, facial reconstructive surgery, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) below the subnasale within 6 months before enrollment
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment
• Abnormal and clinically significant results according to the TI or designee, on hematology, clinical chemistry, or urinalysis
• Females who are pregnant, nursing, or planning a pregnancy during the study
• Tattoos, piercings or scars that would interfere with study visual assessments and 3D measurements of chin area in the judgment of TI
• Trauma to the chin or has residual deficiencies, congenital deformities, or scarring which would impact the trial data evaluation in the judgment of TI
• Menstruation at the time of study intervention (study intervention may be delayed as necessary to accommodate menstrual period cessation)
• The participant has a condition or is in a situation which, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

JUVÉDERM VOLUX®

Experimental group

Description:

Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator.

Treatment:

Device: JUVÉDERM VOLUX®

Control- No treatment

Other group

Description:

No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.

Treatment:

Device: JUVÉDERM VOLUX®