JUVÉDERM VOLUX® for Chin Retrusion in China (NCT04559984) | Clinical Trial Compass
CompletedPhase 3
JUVÉDERM VOLUX® for Chin Retrusion in China
China150 participantsStarted 2020-10-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 e…
What they're measuring
1
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24