Glabellar Frown Lines
Conditions
Brief summary
AI-09 In Subjects with Glabellar Lines
Detailed description
A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.
Interventions
BIOLOGICALAI-09
Injectable Botulinum Toxin Type A
BIOLOGICALVehicle
Vehicle Formulation
Sponsors
Eirion Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* able to understand and give written informed consent * willingness to have their pictures taken * 20 - 70 years of age * moderate to severe glabellar lines (IGA 2-3) on contraction * moderate to severe glabellar lines (SSA 2-3) on contraction * none to mild glabellar lines wrinkles (IGA 0-1) at rest * willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study * female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit * female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) * subjects should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product
Exclusion criteria
* the inability to substantially lessen glabellar lines by physically spreading them apart * excessive weakness or atrophy in the target muscle(s) * eyelid ptosis * presence or history of "dry eye" * history of periocular surgery, brow lift or related procedures, or deep dermal scarring * concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body * history of immunization or hypersensitivity to any botulinum toxin serotype * history of non-response to any prior botulinum toxin treatments * anticipated need for treatment with botulinum toxin of any serotype for a reason during the trial (other than the investigational treatment) * any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * pregnancy or lactation * application of any topical prescription medication to the treatment area within 14 days prior to treatment * subjects on clinically significant, concomitant drug therapy * participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline * alcohol or drug abuse within the past 3 years * psychiatric disease interfering with the subject's ability to give informed consent * refusal or inability to comply with the requirements of the protocol for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1 | 4 Weeks | Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe). | 4 Weeks | % of responders with improvement in the Investigator and Subject's Self Assessment on Contraction, IGA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-3 (0=absent; 3=severe). A "responder" is defined as a change by at least two ordinals assessments. |
Countries
United States
Contacts
STUDY_DIRECTORMichael Eppolito
Eirion Therapeutics
Participant flow
Pre-assignment details
Participants were excluded if they were unable to substantially lessen glabellar lines by physically spreading them apart, had excessive weakness or atrophy in the target muscle(s), eyelid ptosis, presence or history of "dry eye", history of periocular surgery, brow lift or related procedures, or deep dermal scarring, or had used any other botulinum toxin drug product anywhere in the body in the last 6 months.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.0 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 81 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 2 | 0 / 4 | 0 / 6 | 0 / 8 | 0 / 12 | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 4 / 31 | 1 / 2 | 3 / 4 | 2 / 6 | 3 / 8 | 5 / 12 | 3 / 17 | 3 / 16 |
| serious Total, serious adverse events | 0 / 31 | 0 / 2 | 0 / 4 | 0 / 6 | 0 / 8 | 0 / 12 | 0 / 17 | 1 / 16 |
Outcome results
None listed