Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

Phase 1

• Conditions: Facial Rhytides (Forehead Lines, Glabellar Lines); MedDRA version: 18.1Level: LLTClassification code 10048043Term: WrinklingSystem Organ Class: 100000004858; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-001860-36-IE
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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)
- 3 months: any facial nonablative resurfacing laser or light treatment, microdermabrasion, or superficial peels
- 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
- 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 and maximum frown for GL) or 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 repeat 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);Secondary Objective: NA;Primary end point(s): The primary efficacy measures include<br>• 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): Secondary efficacy measures include<br>• subject-rated assessment of treatment satisfaction using Facial Line Satisfaction<br>Questionnaire (FLSQ)<br>• subject-rated assessment of facial line appearance using the FLO-11 Questionnaire<br>• investigator-rated assessment of FHL severity at rest using the FWS<br>• subject-rated assessment of FHL severity at rest using the FWS<br>• investigator-rated assessment of GL severity at maximum frown 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).