Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

January 2, 2016 updated by: Topokine Therapeutics, Inc.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Recruiting
        • Topokine Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAT4 Gel
The participant will apply TAT4 Gel to the nasolabial fold area once daily.
Drug: TAT4 Gel
Placebo Comparator: Placebo
The participant will apply Placebo Gel to the nasolabial fold area once daily.
Drug: Matching placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topokine Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 2, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • TAT4 B1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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