Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

NCT01391312 | Completed Phase 4 Results

• 1 other identifier: GMA-BTXC-11-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30

  Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.

  Day 30

Secondary Outcomes (2)

• Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30

  Day 30

• Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60

  Day 60

Study Arms (2)

botulinum toxin Type A

ACTIVE COMPARATOR

Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Biological: botulinum toxin Type A

placebo (Normal Saline)

PLACEBO COMPARATOR

Normal Saline (placebo) injected into the glabellar region on Day 0.

Drug: normal saline (placebo)

Interventions

botulinum toxin Type A BIOLOGICAL

botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Also known as: BOTOX® Cosmetic, Vistabel®, Vistabax®

botulinum toxin Type A

normal saline (placebo) DRUG

Normal saline (placebo) injected into the glabellar region on Day 0.

placebo (Normal Saline)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe glabellar wrinkles (frown lines)

You may not qualify if:

• Previous treatment with botulinum toxin therapy of any serotype
• Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
• Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
• Mid-facial or periorbital treatment with non-permanent soft tissue fillers
• Subjects planning a facial cosmetic procedure or visible scars
• Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
• Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• History of facial nerve palsy
• A planned extended absence during the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

East Chicago, Illinois, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 25, 2012
• Results First Posted: September 25, 2012

Record last verified: 2012-08

Locations

US (1)