Canthal Lines, Glabellar Frown Lines
Conditions
Brief summary
This study to assess aesthetic improvement following treatment with QM1114-DP.
Detailed description
This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
Interventions
BIOLOGICALQM1114-DP
QM1114-DP
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female 18 years or older * Moderate to severe bilaterally symmetrical LCL as assessed by the investigator * Moderate to severe GL at maximum frown as assessed by the Investigator
Exclusion criteria
* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment * Female who was pregnant, breast feeding or intended to conceive a child during the study. * Known allergy to hypersensitivity or any component of the Investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines) | Month 1 | 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. |
| Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines) | Month 1 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single site in the United States of America from 23 January 2023 to 23 June 2023.
Pre-assignment details
A total of 26 participants were screened. Out of which 25 participants were enrolled and received study product.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
None listed