A Phase 3 interventional study of QM1114-DP and Placebo in Glabellar Frown Lines, sponsored by Galderma R&D. Completed at 9 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Galderma R&D · Phase 3, Interventional, and Treatment
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
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
a Botulinum Toxin Type A (BoNT-A)
Biological: QM1114-DP
Biological: Placebo
QM1114-DP
Placebo
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
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
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
This study was conducted at 9 investigational centers in the United States (US) from 09 May 2022 to 01 September 2023.
| Milestone | Experimental: QM1114-DP | Placebo Comparator: Placebo |
|---|---|---|
| Started | 99 | 33 |
| Completed | 89 | 27 |
| Not completed | 10 | 6 |
| Withdrew: Withdrew consent | 6 | 1 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Other | 1 | 3 |
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).
| Participants | Experimental: QM1114-DP | Placebo Comparator: Placebo |
|---|---|---|
| Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 | 92 | 3 |
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.
| Participants | Experimental: QM1114-DP | Placebo Comparator: Placebo |
|---|---|---|
| Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card | 89 | 3 |
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.
| participants | Experimental: QM1114-DP | Placebo Comparator: Placebo |
|---|---|---|
| Day 1 | 39 (30.10 to 49.49) | 4 (0.99 to 23.26) |
| Day 2 | 66 (58.06 to 76.63) | 4 (1.04 to 23.96) |
| Day 3 | 79 (73.71 to 89.18) | 4 (1.10 to 24.70) |
| Day 4 | 87 (84.79 to 96.46) | 4 (1.10 to 24.70) |
| Month 1 | 92 (89.13 to 98.62) | 3 (0.00 to 20.08) |
| Month 3 | 87 (82.53 to 95.03) | 1 (0.00 to 9.76) |
| Month 6 | 64 (58.66 to 77.51) | 1 (0.00 to 9.76) |
| Month 7 | 51 (45.85 to 66.24) | 1 (0.00 to 10.09) |
| Month 8 | 45 (39.18 to 59.72) | 1 (0.00 to 10.83) |
| Month 9 | 38 (32.42 to 52.97) | 1 (0.00 to 10.83) |
| Month 10 | 32 (26.99 to 47.43) | 0 (0.00 to 0.00) |
| Month 11 | 31 (25.90 to 46.19) | 0 (0.00 to 0.00) |
| Month 12 | 34 (27.76 to 47.79) | 1 (0.00 to 10.09) |
Collected over From Day 1 up to end of study (Up to 12 Months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: QM1114-DP | 0/99 (0%) | 0/99 (0%) | 39/99 (39.4%) |
| Placebo Comparator: Placebo | 0/33 (0%) | 0/33 (0%) | 7/33 (21.2%) |
| Event | Experimental: QM1114-DP | Placebo Comparator: Placebo |
|---|---|---|
| COVID-19Infections and infestations | 7/99 | 3/33 |
| Upper respiratory tract infectionInfections and infestations | 4/99 | 2/33 |
| HeadacheNervous system disorders | 6/99 | 0/33 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/99 | 0/33 |
| SinusitisInfections and infestations | 3/99 | 0/33 |
| Procedural painInjury, poisoning and procedural complications | 3/99 | 0/33 |
| HordeolumInfections and infestations | 1/99 | 1/33 |
| InfluenzaInfections and infestations | 1/99 | 1/33 |
| GastroenteritisInfections and infestations | 0/99 | 1/33 |
| MigraineNervous system disorders | 0/99 | 1/33 |
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.
| Age, Continuous(years) | Experimental: QM1114-DP | Placebo Comparator: Placebo | Total |
|---|---|---|---|
| Mean | 52.1 ± 10.72 | 52.5 ± 10.31 | 52.2 ± 10.58 |
| Sex: Female, Male(Participants) | Experimental: QM1114-DP | Placebo Comparator: Placebo | Total |
|---|---|---|---|
| Female | 94 | 31 | 125 |
| Male | 5 | 2 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: QM1114-DP | Placebo Comparator: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 34 | 13 | 47 |
| Not Hispanic or Latino | 65 | 20 | 85 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental: QM1114-DP | Placebo Comparator: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 0 | 1 | 1 |
| White | 92 | 31 | 123 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 0 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Galderma R&D