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NCT02607670 Clinical Trial

Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

Nasolabial Folds Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02607670
Other study ID # TAT4 B1
Secondary ID
Status Recruiting
Phase Phase 2
First received November 16, 2015
Last updated January 2, 2016
Start date January 2016
Est. completion date September 2016

Study information
Verified date January 2016
Source Topokine Therapeutics, Inc.
Contact Michael S Singer, MD, PhD
Email volunteers@topokine.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 111
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TAT4 Gel

• Matching placebo

Locations
Country Name City State
United States Topokine Research Site Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Topokine Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nasolabial Fold Severity Scale (Clinician-Reported) Day 91 No
See also
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Completed NCT02647853 - Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Phase 1
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