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Completed

NCT Number: NCT02261493

A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).

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Key information

Conditions

Facial Rhytides Glabellar Rhytides

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aalst Dermatology Clinic, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to severe forehead lines, glabellar lines, and crow's feet lines
  • Willing to have facial photos taken

Exclusion criteria

  • Prior exposure to botulinum toxin of any serotype for any indication
  • Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
  • Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
  • Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
  • Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

Treatment and study plan

onabotulinumtoxinA

Biological

OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.

Other names: BOTOX® Cosmetic, botulinum toxin Type A

normal saline

Drug

Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Primary outcomes

  1. Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation

    Time frame: Baseline, Day 30

    The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.

Secondary outcomes

  1. Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation

    Time frame: Day 30

    The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.

  2. Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest

    Time frame: Baseline, Day 30

    The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.

  3. Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5

    Time frame: Day 60

    The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.

  4. Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points

    Time frame: Baseline, Day 30

    The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.

  5. Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©

    Time frame: Baseline, Day 30

    The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis.

  6. Time to Retreatment Eligibility

    Time frame: 12 Months

    Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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