Clinical trial NCT01189760: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Rhytides
Crow's Feet Lines
Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)


Eligibility criteria: Inclusion Criteria:

* Moderate to severe Crow's Feet Lines and Frown Lines
* Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Oral retinoid therapy within one year

Primary outcomes:
measure: Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile
timeFrame: Baseline, Day 30
Secondary outcomes:
measure: Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
timeFrame: Day 30
measure: Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest
timeFrame: Baseline, Day 30
measure: Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score
timeFrame: Day 30
measure: Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
timeFrame: Baseline, Day 30
measure: Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
timeFrame: Baseline, Day 30
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Vancouver
country: Canada
state: British Columbia
city: Antibes
country: France
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.