Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

NCT02580370 | Completed Phase 3

• 1 other identifier: RT001-CL038
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.

Conditions

Skin Aging

Keywords

REALISE 1

Outcome Measures

Primary Outcomes (1)

• Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines

  Week 4

Secondary Outcomes (4)

• Investigator Global Assessment with 2 points or greater improvement from baseline

  Week 4

• Investigator Global Assessment with 1 point or greater improvement from baseline

  Week 4

• Patient Severity Assessment with 2 points or greater improvement from baseline

  Week 4

• Patient Severity Assessment with 1 points or greater improvement from baseline

  Week 4

Study Arms (2)

Dose A

EXPERIMENTAL

Botulinum toxin type A

Biological: Botulinum toxin type A

Dose B

PLACEBO COMPARATOR

Placebo comparator

Biological: Placebo comparator

Interventions

Botulinum toxin type A BIOLOGICAL

Topical botulinum toxin type A

Dose A

Placebo comparator BIOLOGICAL

Topical placebo comparator

Dose B

Eligibility Criteria

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

You may qualify if:

• In good general health
• Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
• Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

You may not qualify if:

• Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
• Muscle weakness or paralysis, particularly in the area receiving study treatment
• Active skin disease or irritation or disrupted barrier at the treatment area
• Active eye disease or irritation
• Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
• Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
• Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
• Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Unknown Facility

Coral Gables, Florida, 33146, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (1)