Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

Phase 2

• Conditions: Nasolabial Folds
• Interventions: Drug: TAT4 Gel; Drug: Matching placebo

• Registration Number: NCT02607670
• Lead Sponsor: Topokine Therapeutics, Inc.

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 available

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-01
• Study Start: 2016-01
• Last Update Submitted: 2016-01-02
• Last Update Posted: 2016-01-05
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAT4 Gel	TAT4 Gel	The participant will apply TAT4 Gel to the nasolabial fold area once daily.
Placebo	Matching placebo	The participant will apply Placebo Gel to the nasolabial fold area once daily.

Primary Outcome Measures

Name	Time	Method
Nasolabial Fold Severity Scale (Clinician-Reported)	Day 91

Trial Locations

Locations (1)

Topokine Research Site; 🇺🇸 Boston, Massachusetts, United States