Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines) MedDRA version: 18.0 Level: LLT Classification code 10048043 Term: Wrinkling System Organ Class: 100000004858
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female, 18 years of age or older - horizontal, symmetrical FHL of moderate to severe rating at maximum eyebrow elevation as assessed by both the subject and the investigator using the FWS at day 1 prior to study treatment; investigator and subject baseline FHL ratings at maximum eyebrow elevation must be identical - GL of moderate to severe rating at maximum frown as assessed by the investigator using the FWS at day 1 prior to study treatment - bilaterally symmetrical LCL of moderate to severe rating at maximum contraction (maximum smile) as assessed by the investigator using the FWS at day 1 prior to study treatment 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 675 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: - prior exposure to botulinum toxin of any serotype for any reason - any of the following procedures or treatments occurring in the specified period prior to enrollment (day 1): a- 3 months: any facial nonablative resurfacing laser or light treatment, microdermabrasion, or superficial peels b- 6 months: any facial cosmetic procedure with medium depth or deep depth facial chemical peels (eg, trichloroacetic acid and phenol); periorbital, midfacial, or upper facial skin resurfacing; or permanent make-up in the midfacial (extending from inferior orbital margin to level of the nasal base) or upper facial areas c- 12 months: any periorbital, midfacial, or upper facial treatment with nonpermanent soft tissue fillers, or treatment with oral retinoids - prior periorbital surgery, facial lift (full-face or mid-face), thread lift, eyebrow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery) - prior periorbital, midfacial or upper facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation - marked periocular and eyebrow asymmetry assessed by the investigator at maximum contraction (maximum eyebrow elevation for FHL, maximum frown for GL, or maximum smile for LCL) or at rest - marked dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator - any eyebrow ptosis or eyelid ptosis at baseline, or excessive forehead and eyebrow skin laxity, as determined by the investigator - eyelid folds that reach the pupil or touch the upper lash line - use of the frontalis muscle to move the upper eyelid, as assessed by the investigator - females who are pregnant, nursing, or planning a pregnancy during the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to evaluate the safety and efficacy of BOTOX treatment for forehead lines (FHL), defined as treatment of the frontalis muscle (eyebrow elevator) with simultaneous treatment of the glabellar complex (procerus and corrugator muscles and eyebrow depressors) - to evaluate the safety of repeat BOTOX treatment of facial rhytides in the forehead, glabellar, and lateral canthal areas simultaneously;Secondary Objective: NA;Primary end point(s): - investigator-rated assessment of FHL severity at maximum eyebrow elevation using the FWS - subject-rated assessment of FHL severity at maximum eyebrow elevation using the FWS;Timepoint(s) of evaluation of this end point: The primary efficacy variables will be evaluated across all study visits, with the primary timepoint being day 30 of Period 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - subject-rated assessment of FHL/GL treatment impact and treatment satisfaction using Facial Line Satisfaction Questionnaire© (FLSQ) - subject-rated assessment of facial line appearance using the Facial Line Outcomes (FLO-11) Questionnaire© - investigator-rated assessment of FHL severity at rest using the FWS - subject-rated assessment of FHL severity at rest using the FWS - investigator-rated assessment of GL severity at maximum frown using the FWS - investigator-rated assessment of LCL severity at maximum smile using the FWS;Timepoint(s) of evaluation of this end point: The secondary efficacy variables will be evaluated across all study visits, with the primary timepoint being day 30 of Period 1 (except FLSQ item 5, for which the primary timepoint is day 60 of Period 1). | — |
Countries
Belgium, Canada, Germany, United Kingdom, United States
Contacts
Public ContactAllergan Ltd. EU Regulatory Affairs
Allergan Limited
Outcome results
None listed