Glabellar Lines
Conditions
Keywords
Glabellar Lines, OnabotulinumtoxinA X, BOTOX
Brief summary
Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL . OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B & C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States. Participants will receive one dose of OnabotA X administered as 5 injections on Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGFormulation A: OnabotulinumtoxinA
Intramuscular Injection
DRUGFormulation B: OnabotulinumtoxinA
Intramuscular Injection
DRUGFormulation C: OnabotulinumtoxinA
Intramuscular Injection
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines. * Participant has severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.
Exclusion criteria
* History of known immunization to any botulinum toxin serotype. * History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class. * Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotA X or interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * History of facial nerve palsy * Infection or dermatological condition at the site of study drug injection * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart * Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to Day 180 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Formulation A: OnabotulinumtoxinA Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection | 29 |
| Formulation B: OnabotulinumtoxinA Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation B: OnabotulinumtoxinA: Intramuscular Injection | 31 |
| Formulation C: OnabotulinumtoxinA Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation C: OnabotulinumtoxinA: Intramuscular Injection | 31 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.47 | 45.7 years STANDARD_DEVIATION 9.97 | 49.4 years STANDARD_DEVIATION 9.96 | 49.0 years STANDARD_DEVIATION 10.69 |
| Age, Customized 18-25 years | 1 participants | 2 participants | 0 participants | 3 participants |
| Age, Customized 26-40 years | 3 participants | 6 participants | 7 participants | 16 participants |
| Age, Customized 41-55 years | 12 participants | 18 participants | 15 participants | 45 participants |
| Age, Customized 56-64 years | 10 participants | 3 participants | 8 participants | 21 participants |
| Age, Customized >=65 years | 3 participants | 2 participants | 1 participants | 6 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 6 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 25 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 31 Participants | 28 Participants | 86 Participants |
| Sex: Female, Male Female | 29 Participants | 31 Participants | 31 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 4 / 29 | 9 / 32 | 7 / 31 |
| serious Total, serious adverse events | 0 / 29 | 1 / 32 | 0 / 31 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
Time frame: Day 1 to Day 180
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Formulation A: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Emergent Adverse Events (TEAE) | 7 Participants |
| Formulation A: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Drug | 2 Participants |
| Formulation A: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Procedure | 0 Participants |
| Formulation A: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Treatment | 2 Participants |
| Formulation B: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Drug | 3 Participants |
| Formulation B: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Procedure | 4 Participants |
| Formulation B: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Treatment | 5 Participants |
| Formulation B: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Emergent Adverse Events (TEAE) | 15 Participants |
| Formulation C: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Procedure | 1 Participants |
| Formulation C: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Treatment | 1 Participants |
| Formulation C: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Emergent Adverse Events (TEAE) | 9 Participants |
| Formulation C: OnabotulinumtoxinA | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE Related to Study Drug | 1 Participants |