Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
- Conditions
- Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)MedDRA version: 17.0Level: LLTClassification code 10048043Term: WrinklingSystem Organ Class: 100000004858
- Registration Number
- EUCTR2014-001815-38-BE
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>(procerus and corrugator muscles and eyebrow depressors)<br>- 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<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - subject-rated assessment of FHL/GL treatment impact and treatment satisfaction using Facial Line Satisfaction Questionnaire© (FLSQ)<br>- subject-rated assessment of facial line appearance using the Facial Line Outcomes (FLO-11) Questionnaire©<br>- investigator-rated assessment of FHL severity at rest using the FWS<br>- investigator-rated assessment of GL severity at maximum frown using the FWS<br>- 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).