Safety Study of Two Repeat Doses of RT001 for the Treatme... | NCT01124565

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

NCT01124565

Sponsor

Revance Therapeutics, Inc.

Status

Completed

Last Update Posted

Jan 17, 2014Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Lateral Canthal Lines
Crow's Feet
Facial Wrinkles

Interventions

RT001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

May 12, 2010

First Submission Date that Met QC Criteria

May 13, 2010

First Posted Date

May 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 13, 2011

Certification/Extension First Submitted that Passed QC Review

Jun 13, 2011

Certification/Extension First Posted Date

Jun 27, 2011Estimated

Last Update Submitted Date

Dec 16, 2013

Last Update Posted Date

Jan 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RT001	Experimental	RT001 (Botulinum Toxin Type A) Topical Gel	Drug: RT001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RT001	Drug	RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas	RT001

Measure	Description	Time Frame
Assessment of treatment-emergent adverse events based on safety assessments.		4 weeks and 8 weeks

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joel Schlessinger, M.D.	Skin Specialists, PC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Total Skin & Beauty Dermatology Center, PC		Birmingham	Alabama	35205	United States
Therapeutics Clinical Research