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)

Allergan Limited0 sites750 target enrollmentSeptember 30, 2014

ConditionsFacial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)MedDRA version: 18.0Level: LLTClassification code 10048043Term: WrinklingSystem Organ Class: 100000004858 Therapeutic area: Not possible to specify

DrugsBOTOX®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
Sponsor: Allergan Limited
Enrollment: 750
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 30, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergan Limited

Eligibility 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

•\- 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