Open Label Study to Assess Long-term Safety of Repeat Adm... | NCT01818076

Studies
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

NCT01818076

Sponsor

Revance Therapeutics, Inc.

Status

Terminated

Last Update Posted

May 7, 2014Estimated

Enrollment

311Actual

Phase

Phase 3

Conditions

Skin Aging

Interventions

Botulinum Toxin Type A

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to terminate study (not due to safety reasons)

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 26, 2013Estimated

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

Dec 18, 2013

Certification/Extension First Submitted that Passed QC Review

Dec 18, 2013

Certification/Extension First Posted Date

Jan 24, 2014Estimated

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

May 7, 2014Estimated

Description Module

Brief Summary

This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose A	Experimental	Dose A: Botulinum toxin type A	Drug: Botulinum Toxin Type A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug	Botulinum toxin type A, Dose A applied to the lateral canthal area	Dose A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments		Up to 24 months
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments		Up to 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe crow's feet lines
Female or male, 18 years of age and above and in good general health
Women of childbearing potential must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
Muscle weakness or paralysis, particularly in the area receiving study treatment
Active skin disease or irritation at the treatment area
Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
Treatment with botulinum toxin type A for crow's feet lines in the last 3 months
Chemical peel during the 9 months prior to treatment
Use of prescription retinoid products during the 3 months prior to treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nashville Centre for Laser and Facial Surgery		Nashville	Tennessee	37203	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided