Canthal Lines
Conditions
Keywords
Canthal lines
Brief summary
This double-blind study has two parts for each subject (same population): Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled): * To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs. * To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo. Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year): * To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs. * To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs. * To assess the subjects' level of satisfaction with the appearance of their LCLs.
Interventions
DRUGBotulinum Toxin Type A
During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
OTHERPlacebo
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, 18 to 65 years of age (Screening visit), * Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines at maximum smile determined by investigator at screening and baseline * Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines at rest determined by investigator at screening and baseline * The subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at screening and baseline * Subjects who are not satisfied with their appearance at screening and baseline * The subject is willing and able to comply with the requirements of the protocol and agree to adhere to the visit schedule, concomitant therapy prohibitions and must be compliant to the study instruction. * The subject agrees to participate in the study, verified by dating and signing an approved written Informed Consent Form (ICF) and Photography Consent Form (PCF) (selected sites only if applicable) at the enrolment visit before any study procedures at screening
Exclusion criteria
* Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the investigator. * Previous insertion of any permanent, semi-permanent or biodegradable material in the periorbital region or facial treatment with augmentation material (e.g. silicon injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12 months prior to screening. * Any prior treatment with botulinum toxin (of any serotype) * Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser) or treatment with deep chemical peels and any other esthetic or dermatologic treatments or procedures in any area of the face within 12 months prior to screening. * Any planned facial cosmetic surgery or procedures during the study period. * Presence of any bleeding disorders * Pregnant or lactating women or women who are planning pregnancy during the study. * Known hypersensitivity to any of the test materials or related compounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders on the Severity of Lateral Canthal Lines at Maximum Smile. | Week 4 | A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines | Week 4 | Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied. A participant is considered satisfied if he/she answers Very satisfied or Satisfied. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. | 252 |
| Placebo During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. | 83 |
| Total | 335 |
Baseline characteristics
| Characteristic | Placebo | Total | Botulinum Toxin Type A |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 8.1 | 48.7 years STANDARD_DEVIATION 8.5 | 48.5 years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Caucasian | 83 Participants | 332 Participants | 249 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment France | 31 participants | 123 participants | 92 participants |
| Region of Enrollment Germany | 39 participants | 160 participants | 121 participants |
| Region of Enrollment United Kingdom | 13 participants | 52 participants | 39 participants |
| Sex: Female, Male Female | 74 Participants | 308 Participants | 234 Participants |
| Sex: Female, Male Male | 9 Participants | 27 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 83 | 0 / 326 |
| other Total, other adverse events | 0 / 252 | 0 / 83 | 0 / 326 |
| serious Total, serious adverse events | 5 / 252 | 1 / 83 | 11 / 326 |
Outcome results
Primary
Number of Responders on the Severity of Lateral Canthal Lines at Maximum Smile.
A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Botulinum Toxin Type A | Number of Responders on the Severity of Lateral Canthal Lines at Maximum Smile. | 119 Participants |
| Placebo | Number of Responders on the Severity of Lateral Canthal Lines at Maximum Smile. | 6 Participants |
Secondary
Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines
Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied. A participant is considered satisfied if he/she answers Very satisfied or Satisfied.
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Botulinum Toxin Type A | Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines | 165 Participants |
| Placebo | Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines | 14 Participants |