Overview

This trial is active, not recruiting.

Conditions upper facial rhytides, crow's feet lines, glabellar lines, frown lines
Treatments botulinum toxin type a (44 u), botulinum toxin type a (32 u)
Phase phase 3
Sponsor Allergan
Start date February 2013
End date July 2013
Trial size 101 participants
Trial identifier NCT01797094, 191622-122

Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
botulinum toxin type a (44 u) BOTOX®
44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
(Experimental)
32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
botulinum toxin type a (32 u) BOTOX®
32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.

Primary Outcomes

Measure
Investigator's Assessment of the Severity of Crow's Feet Lines at Maximum Smile Using the Facial Wrinkle Scale
time frame: Day 30

Secondary Outcomes

Measure
Subject's Assessment of Change in Appearance of Crow's Feet Lines as Measured by a 7-point Scale
time frame: Day 30
Subject's Assessment of Appearance of Crow's Feet Lines as Measured by the Facial Line Outcomes Questionnaire
time frame: Day 30
Subject's Assessment of Age-related Facial Appearance as Measured by the Self-Perception of Age Questionnaire
time frame: Day 30
Subject's Assessment of Satisfaction with Treatment as Measured by the Facial Line Satisfaction Questionnaire
time frame: Day 30

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

Inclusion Criteria: -Moderate to severe Crow's Feet Lines and Frown Lines Exclusion Criteria: - Current or previous botulinum toxin treatment of any serotype - Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis - Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months - Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year - Medium-depth or deep facial peels within 5 years - Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)

Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Allergan.