Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds | NCT02607670

Studies
Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

NCT02607670

Sponsor

Topokine Therapeutics, Inc.

Status

Unknown status

Last Update Posted

Jan 5, 2016Estimated

Enrollment

111Estimated

Phase

Phase 2

Conditions

Nasolabial Folds

Interventions

TAT4 Gel
Matching placebo

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Aug 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Nov 16, 2015

First Submission Date that Met QC Criteria

Nov 16, 2015

First Posted Date

Nov 18, 2015Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2016

Last Update Posted Date

Jan 5, 2016Estimated

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 is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAT4 Gel	Experimental	The participant will apply TAT4 Gel to the nasolabial fold area once daily.	Drug: TAT4 Gel
Placebo	Placebo Comparator	The participant will apply Placebo Gel to the nasolabial fold area once daily.	Drug: Matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAT4 Gel	Drug		TAT4 Gel
Matching placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasolabial Fold Severity Scale (Clinician-Reported)		Day 91

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe, bilateral nasolabial folds
Must understand and provide informed consent

Exclusion Criteria:

Pregnant or lactating women
History of skin hypersensitivity of atopic dermatitis
Any illness of disease that, in the investigator's opinion, would make trial participation inadvisable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael S Singer, MD, PhD	Contact			volunteers@topokine.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topokine Research Site	Recruiting	Boston	Massachusetts		United States