Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

NCT01064518 | Completed Phase 2

• 1 other identifier: RT001-CL024LCL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

Conditions

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Keywords

Lateral Canthal Lines; Crow's Feet Wrinkles; Facial Wrinkles

Outcome Measures

Primary Outcomes (1)

• The number of subjects who show improvement based on the investigator global and patient assessments.

  Week 4

Secondary Outcomes (1)

• The number of subjects who show improvement based on the investigator global and patient assessments.

  Week 8

Study Arms (2)

Dose A

ACTIVE COMPARATOR

RT001 Topical Gel

Drug: Botulinum Toxin Type A

Dose B

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo (Dose B)

Interventions

Botulinum Toxin Type A DRUG

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines

Dose A

Placebo (Dose B) DRUG

Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines

Dose B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent including authorization to release health information
• Female or male, 18 to 65 years of age and in good general health
• Willing and able to follow study instructions and likely to complete all study requirements
• Moderate to severe lateral canthal lines (crow's feet wrinkles)

You may not qualify if:

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
• Muscle weakness or paralysis, particularly in the area receiving study treatment
• Active disease or irritation at the treatment areas including the eye and the skin
• Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
• Previous participation in a RT001 clinical study

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Dermatology Research Institute, LLC

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 Officials

• Fredric Brandt, MD

  Dermatology Research Institute, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

US (1)