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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01064518
Other study ID # RT001-CL024LCL
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2010
Est. completion date July 2010

Study information

Verified date August 2020
Source Revance Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Dermatology Research Institute, LLC Coral Gables Florida

Sponsors (1)

Lead Sponsor Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of subjects who show improvement based on the investigator global and patient assessments. Week 4
Secondary The number of subjects who show improvement based on the investigator global and patient assessments. Week 8
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