Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation (NCT NCT02396251)

Last Updated: 2022-08-26

Results Overview

Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.

Recruitment status

TERMINATED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

3 months

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Both Cheeks Group HA product under investigation in both cheeks	Split-face Group HA product under investigation in one cheek and a comparator in the other cheek.
Overall Study STARTED	36	12
Overall Study COMPLETED	23	7
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Both Cheeks Group n=36 Participants HA product under investigation in both cheeks	Split-face Group n=12 Participants HA product under investigation in one cheek and a comparator in the other cheek.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	11 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 11 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	42 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	12 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	11 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	36 Participants n=5 Participants	12 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The primary objective applied to the group treated with the investigational HA product in both cheeks. Only exploratory objective applied to the split-face group.

Outcome measures

Outcome measures
Measure	Both Cheeks Group n=31 Participants Subjects with at least 1 step improvement on validated photo scale in both cheeks as assessed by the Blinded evaluator, Both cheeks group
Percentage of Responders in Midface Fullness Using Photo Scale	93.5 percentage of participants Interval 78.6 to 99.2

SECONDARY outcome

Timeframe: 15 months

Population: Number of participants with available data varied during the study. The secondary objective applied to the group treated with the investigational HA product in both cheeks. Only exploratory objective applied to the split-face group.

Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.

Outcome measures

Outcome measures
Measure	Both Cheeks Group n=34 Participants Subjects with at least 1 step improvement on validated photo scale in both cheeks as assessed by the Blinded evaluator, Both cheeks group
Percentage of Responders in Midface Fullness Using Photo Scale 4 weeks after last treatment	88.2 percentage of participants Interval 72.5 to 96.7
Percentage of Responders in Midface Fullness Using Photo Scale 3 months	93.5 percentage of participants Interval 78.6 to 99.2
Percentage of Responders in Midface Fullness Using Photo Scale 6 months	90 percentage of participants Interval 73.5 to 97.9
Percentage of Responders in Midface Fullness Using Photo Scale 9 months	81.5 percentage of participants Interval 61.9 to 93.7
Percentage of Responders in Midface Fullness Using Photo Scale 12 months	43.3 percentage of participants Interval 25.5 to 62.6
Percentage of Responders in Midface Fullness Using Photo Scale 15 months	25 percentage of participants Interval 8.7 to 49.1
Percentage of Responders in Midface Fullness Using Photo Scale 4 weeks after re-treatment	100 percentage of participants Interval 47.8 to 100.0
Percentage of Responders in Midface Fullness Using Photo Scale 3 months after re-treatment	100 percentage of participants Interval 39.8 to 100.0

Adverse Events

Both Cheeks Group

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Split-face Group

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Both Cheeks Group n=36 participants at risk HA product under investigation in both cheeks	Split-face Group n=12 participants at risk HA product under investigation in one cheek and a comparator in the other cheek.
Gastrointestinal disorders Anal prolapse	0.00% 0/36 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	8.3% 1/12 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Cardiac disorders Angina pectoris	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
General disorders Chest pain	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Investigations Elevated TNT	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Infections and infestations Epiglottitis	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Injury, poisoning and procedural complications Unstable patella	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Respiratory, thoracic and mediastinal disorders Postoperative tachypnea	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.
Injury, poisoning and procedural complications Scar left cheek	2.8% 1/36 • Number of events 1 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.	0.00% 0/12 • 2 years, 9 months (from first subject screening to last subject's last visit). Groups for each intervention separately cannot be provided since most of the Adverse Events (AEs) are not related to study product. Analysis groups were "Both cheeks group" and "Split-face group" (as presented here). In the Split-face group, only two AEs were assessed as related to study product/device injection procedure: the AE "Implant site pain" which was assessed as related to the HA product under investigation, and the AE "Eye pain" which was not assessed as related to a specific product.

Other adverse events

Additional Information

Reception

Galderma

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place