Glabellar Frown Lines
Conditions
Brief summary
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
Interventions
BIOLOGICALQM1114-DP
QM1114-DP
BIOLOGICALPlacebo
Placebo
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Parallel assignment
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 GL at maximum frown as assessed by the Investigator * Moderate to severe GL at maximum frown as assessed by the subject
Exclusion criteria
* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment * Female who is pregnant, breast feeding or intends to conceive a child during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | At Month 1 | Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded improved, much improved, or very much improved on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | At Days 0 through 7 post-treatment | Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond yes or no to the following question: Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown? Response to treatment effect given by a Participant on first day as yes to the diary question. |
| Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | From Day 1 through Month 12 | Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded improved, much improved, or very much improved on the GAIS at maximum frown. This analysis is based on observed cases. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 9 investigational centers in the United States (US) from 09 May 2022 to 01 September 2023.
Pre-assignment details
A total of 132 participants were enrolled and treated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: QM1114-DP Participants received a single dose of 50 U (0.5 mL) QM1114-DP IM, divided into 5 equal aliquots injected into the glabellar area (10 U \[0.1 mL\] per injection point). | 99 |
| Placebo Comparator: Placebo Participants received a single dose of 0.5 mL placebo IM, divided into 5 equal aliquots injected into the glabellar area (0.1 mL per injection point). | 33 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Withdrew consent | 6 | 1 |
Baseline characteristics
| Characteristic | Placebo Comparator: Placebo | Total | Experimental: QM1114-DP |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 10.31 | 52.2 years STANDARD_DEVIATION 10.58 | 52.1 years STANDARD_DEVIATION 10.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 47 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 85 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 31 Participants | 123 Participants | 92 Participants |
| Sex: Female, Male Female | 31 Participants | 125 Participants | 94 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 33 |
| other Total, other adverse events | 39 / 99 | 7 / 33 |
| serious Total, serious adverse events | 0 / 99 | 0 / 33 |
Outcome results
Primary
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded improved, much improved, or very much improved on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).
Time frame: At Month 1
Population: Intent to treat (ITT) population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | 92 Participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | 3 Participants |
p-value: <0.00195% CI: [72.81, 94.87]Cochran-Mantel-Haenszel
Secondary
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12
Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded improved, much improved, or very much improved on the GAIS at maximum frown. This analysis is based on observed cases.
Time frame: From Day 1 through Month 12
Population: ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme. Here, number analyzed signifies participants in total observed cases at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 3 | 79 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 7 | 51 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 1 | 92 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 8 | 45 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 2 | 66 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 9 | 38 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 3 | 87 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 10 | 32 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 4 | 87 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 11 | 31 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 6 | 64 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 12 | 34 participants |
| Experimental: QM1114-DP | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 1 | 39 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 12 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 1 | 4 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 2 | 4 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 3 | 4 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Day 4 | 4 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 1 | 3 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 3 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 6 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 7 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 8 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 9 | 1 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 10 | 0 participants |
| Placebo Comparator: Placebo | Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 | Month 11 | 0 participants |
Secondary
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card
Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond yes or no to the following question: Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown? Response to treatment effect given by a Participant on first day as yes to the diary question.
Time frame: At Days 0 through 7 post-treatment
Population: ITT population included all participants who were randomized and analyzed according to the treatment they were randomized based on the randomization scheme.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: QM1114-DP | Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | 89 Participants |
| Placebo Comparator: Placebo | Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | 3 Participants |