Treatment of lateral canthal rhytides in the periorbital region (Crow's Feet Lines) MedDRA version: 13.1 Level: PT Classification code 10040954 Term: Skin wrinkling System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 18 years of age or older 2. Presence of bilaterally symmetrical CFL of moderate to severe rating at maximum smile, as measured using the FWS by both the investigator and subject at day 1(prior to study treatment) (investigator and subject rating at maximum smile must be the same) 3. Subjects must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable), to accurately assess their facial wrinkles 4. Female subjects of childbearing potential must have a negative urine pregnancy test at day 1 prior to study treatment. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus. 5. Written informed consent has been obtained 6. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and Data Protection Consent (European sites only) and/or other documentation in accordance with the relevant country and local privacy requirements has been obtained 7. Ability to follow study instructions and likely to complete all required visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 223 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 222
Exclusion criteria
Exclusion criteria: 1. Any condition which precludes a subject’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess CFL severity using the FWS 2. Concurrent or previous botulinum toxin treatment of any serotype 3. Known immunization or hypersensitivity to any botulinum toxin serotype 4. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment) 5. Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function 6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures 7. Any of the following procedures or treatments occurring in the specified period prior to enrollment (day 1) a. 3 months: Non-ablative resurfacing laser or light treatment, microdermabrasion or superficial peels b. 6 months: Any facial cosmetic procedure with medium depth to deep facial chemical peels (eg, trichloroacetic acid [TCA] and phenol), or mid facial or periorbital laser skin resurfacing c. 12 months: Mid facial or periorbital treatment with non-permanent soft tissue fillers 8. Subjects on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain the same regimen for the study 9. Subjects on oral retinoid therapy within 1 year prior to study enrollment 10. Prior periorbital surgery, facial lift (full face or mid face), brow lift, or related procedures (eg, eyelid (blepharoplasty) and/or eyebrow surgery) 11. Prior mid face or periorbital treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation 12. Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial rhytides even by physically spreading them apart, as determined by the investigator 13. Presence of any clinically relevant abnormal finding as observed from the neurologic assessment (See Protocol) 14. Any eyebrow or eyelid ptosis at baseline as determined by the investigator 15. Infection or skin disorder at the injection sites 16. History of facial nerve palsy 17. Females who are pregnant, nursing, or planning a pregnancy 18. Females of childbearing potential, not using a reliable means of contraception 19. Any uncontrolled systemic disease 20. Recent history of alcohol or drug abuse based on the investigator’s judgment 21. Anticipated need for surgery or overnight hospitalization during the study 22. Subjects who plan for an extended absence away from the immediate area of the study center that would preclude them from returning for all protocol specified study visits 23. Subjects who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period 24. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study 25. Permanent make-up which would interfere with the assessment of facial wrinkles 26. Subject has a condition or is in a situation which in the investigator'
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of BOTOX compared to placebo in subjects with lateral canthal rhytides in the periorbital region (Crow's Feet Lines).;Secondary Objective: N/A;Primary end point(s): The co-primary efficacy endpoints are the proportion of subjects achieving a grade of none or mild on the investigator’s and on the subject’s assessment of the severity of CFL at maximum smile, based on the FWS.;Timepoint(s) of evaluation of this end point: day 30 of the first treatment cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Secondary efficacy endpoints are: 1. The proportion of responders of the investigator’s FWS in CFL at rest at day 30, among subjects who were rated as at least mild at baseline, where a responder is defined as achieving a 1-grade improvement on the investigator-rated FWS at rest in CFL. 2. The proportion of responders of the investigator’s FWS in CFL at maximum smile at day 30, where a responder is defined as achieving a 1-grade improvement on the investigator-rated FWS at maximum smile in CFL. 3. The proportion of responders of the investigator’s FWS in CFL at maximum smile at day 30, where a responder is defined as achieving a rating of none or mild on the investigator-rated FWS at maximum smile in CFL (for US FDA only). 4. Values at day 30 for the subject’s Global Assessment of Change in CFL (using a 7-point scale) will be analyzed using analysis of variance (ANOVA) with treatment, as the main effect. 5. The proportion of subjects with a = 2 point improvement over baseline for FLO item #2 at day 30: When I look in the mirror, my facial lines make me look older than I want to look. 6. The proportion of subjects with a = 2 point improvement over baseline for FLO item #5 at day 30: My facial lines make me look less attractive. 7. The proportion of subjects with a = 3 point improvement over baseline for FLO item #8 at day 30: My facial lines make me look tired. 8. Analysis will be performed on the proportion of subjects at day 30, who rate themselves in a younger SPA category than at baseline (ie, from “look my current age” at baseline to “look younger” or from “look older” at baseline to “look my current age/younger”). Only subjects who rated themselves as looking their current age or older at baseline will be included in the denominator of this analysis.;Timepoint(s) of evaluation of this end point: At Day 30. | — |
Countries
Belgium, Canada, United Kingdom, United States
Contacts
Public ContactAllergan Ltd, EU Regulatory Affairs
Allergan Ltd
Outcome results
None listed