Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

NCT01818076 | Terminated Phase 3

• 1 other identifier: RT001-CL023
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (2)

• Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments

  Up to 24 months

• Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments

  Up to 24 months

Study Arms (1)

Dose A

EXPERIMENTAL

Dose A: Botulinum toxin type A

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

Botulinum toxin type A, Dose A applied to the lateral canthal area

Dose A

Eligibility Criteria

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

You may qualify if:

• Moderate to severe crow's feet lines
• Female or male, 18 years of age and above and in good general health
• Women of childbearing potential must agree to use an effective method of birth control during the course of the study

You may not qualify if:

• Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
• Muscle weakness or paralysis, particularly in the area receiving study treatment
• Active skin disease or irritation at the treatment area
• Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
• Treatment with botulinum toxin type A for crow's feet lines in the last 3 months
• Chemical peel during the 9 months prior to treatment
• Use of prescription retinoid products during the 3 months prior to treatment

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 26, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

US (1)