Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Facial Wrinkles Clinical Trial

Official title:

A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124565
• Other study ID #: RT001-CL025LCL
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2010
• Last updated: December 16, 2013
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: December 2013
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Description:

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 child bearing potential (WOCBP) but is not willing to use an effective method of birth control

• Previous participation in a RT001 clinical study

• Previous treatment with botulinum toxin (any serotype)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• RT001
RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Locations

Country	Name	City	State
United States	Total Skin & Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Therapeutics Clinical Research	San Diego	California

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	Assessment of treatment-emergent adverse events based on safety assessments.		4 weeks and 8 weeks	Yes