Jawline Definition Deficiency
Conditions
Brief summary
This study is designed to evaluate effectiveness and safety of GP0109 for Jawline definition
Interventions
DEVICEGP0109
Treatment of the Jawline
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or non-pregnant, non-breastfeeding females, over the age of 21.
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins * Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS) | At Month 3 | The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently. |
Countries
Puerto Rico
Participant flow
Recruitment details
This study was conducted at 15 investigative sites in the United States from 15 November 2021 to 23 October 2024.
Pre-assignment details
A total of 245 participants were screened for the study, of which 21 were screen failures. Of the 224 randomized participants, 56 were randomly assigned to the no treatment group and 168 were randomly assigned to receive GP0109 injection at baseline stratified by injection tool (needle, cannula and both needle and cannula combined) and Fitzpatrick skin type (FST) group (I-III, IV and V-VI).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 186 Participants |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 1 / 214 | 0 / 100 |
| other Total, other adverse events | 0 / 56 | 12 / 214 | 5 / 100 |
| serious Total, serious adverse events | 0 / 56 | 9 / 214 | 1 / 100 |
Outcome results
None listed