Trial Outcomes & Findings for Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines (NCT NCT05148000)
NCT ID: NCT05148000
Last Updated: 2026-05-29
Results Overview
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown.
COMPLETED
PHASE3
25 participants
Month 1
2026-05-29
Participant Flow
This study was conducted at a single site in the United States of America from 23 January 2023 to 23 June 2023.
A total of 26 participants were screened. Out of which 25 participants were enrolled and received study product.
Participant milestones
| Measure |
QM1114-DP
Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
Baseline characteristics by cohort
| Measure |
QM1114-DP
n=25 Participants
Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0.
|
|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.10 • n=51 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Analysis was performed on the full analysis set which included all participants who were injected in both glabellar lines and lateral canthal lines.
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown.
Outcome measures
| Measure |
QM1114-DP
n=25 Participants
Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0.
|
|---|---|
|
Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines)
|
100 percentage of participants
Interval 86.28 to 100.0
|
PRIMARY outcome
Timeframe: Month 1Population: Analysis was performed on the full analysis set which included all participants who were injected in both glabellar lines and lateral canthal lines.
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile.
Outcome measures
| Measure |
QM1114-DP
n=25 Participants
Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0.
|
|---|---|
|
Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines)
|
100 percentage of participants
Interval 86.28 to 100.0
|
Adverse Events
QM1114-DP
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
QM1114-DP
n=25 participants at risk
Participants received intramuscular injections of QM1114-DP 50 units in the glabellar region and QM1114-DP 60 units in the lateral canthus lines areas on Day 0.
|
|---|---|
|
General disorders
Injection site bruising
|
8.0%
2/25 • From Day 0 up to Month 4
Analysis was performed on the safety set which included all participants who were injected in at least one of the glabellar lines and lateral canthal lines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place