Trial Outcomes & Findings for Pan Facial Volume Restoration (NCT NCT01545557)

Results Overview

Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 18 Months after last injection

Results posted on

2023-03-01

Participant Flow

Sixty subjects were recruited across 4 sites in Brazil (15 subjects per site) between February 2012 and October 2013.

Participant milestones

Participant milestones
Measure	Hyaluronic Acid Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pan Facial Volume Restoration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyaluronic Acid n=60 Participants Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary
Age, Continuous	53.5 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	53 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	1 Participants n=5 Participants
Region of Enrollment Brazil	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 18 Months after last injection

Population: ITT population included all participants who were injected.

Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.

Outcome measures

Outcome measures
Measure	Volume loss18 Months After Injection n=60 Participants Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections
Mean Change From Baseline in Volume Loss Assessment	-0.8 Score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: At 3 Weeks after last injection

Population: ITT population included all participants who were injected. Here, 'overall number of participants analyzed' signifies participants who completed a questionnaire about their satisfaction with the overall, full face aesthetic outcome.

Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.

Outcome measures

Outcome measures
Measure	Volume loss18 Months After Injection n=59 Participants Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection Satisfied	32.2 Percentage of participants
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection Very satisfied	67.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 18 Months after last injection

Population: Here overall number of participants analyzed refers to the study investigators who completed a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler.

The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Volume loss18 Months After Injection n=7 Participants Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 18 Months after last injection

Population: The safety population was defined as all participants who were injected with the study product.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Volume loss18 Months After Injection n=60 Participants Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections
Number of Participants With Adverse Events (AEs)	9 Participants

SECONDARY outcome

Timeframe: At 18 Months after last injection

Population: All injected subjects satisfied to very satisfied

Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.

Outcome measures

Outcome measures
Measure	Volume loss18 Months After Injection n=60 Participants Full face volume loss 18 months after last injections for all subjects having received Hyaluronic Acid injections
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection Satisfied	25 percentage of participants
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection Very satisfied	70 percentage of participants

Adverse Events

Hyaluronic Acid

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hyaluronic Acid n=60 participants at risk Hyaluronic acid dermal filler gel: 1 injection per indication and 1 touch-up injection if necessary
Musculoskeletal and connective tissue disorders Back pain	3.3% 2/60 • Number of events 3 • From Baseline up to 18 Months after last injection

Additional Information

Clinical project manager

Galderma

Phone: 817-961-5655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any intent of Institution and Investigator/Researcher to publish or disclose in any way Information requires Sponsor's prior written approval. Investigator/Researcher shall provide his draft of such publication to Sponsor for review and approval at least two months prior to the date of intended publication. Sponsor hereby agrees he shall endeavour to preserve accuracy of results in authorized publications and negative as well as positive results shall be published or made publicly available.
Publication restrictions are in place

Restriction type: OTHER