Clinical Trials Logo
  1. Home
  2. Nasolabial Folds
  3. NCT02607670
  4. Details
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
  Status Clinical Trial Phase
Active, not recruiting NCT06018987 - A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds Phase 2/Phase 3
Completed NCT01115634 - Autologous Fibroblast Transplantation in Facial Deformities Phase 2
Completed NCT01012661 - Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler Phase 4
Completed NCT00778531 - Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds Phase 4
Completed NCT03932045 - A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds N/A
Completed NCT02647853 - Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Phase 1
Completed NCT01069354 - Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds N/A
Completed NCT00797459 - Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds N/A
Completed NCT00850889 - Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds Phase 4
Recruiting NCT06093321 - A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement N/A
Not yet recruiting NCT06295172 - A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement N/A
Completed NCT01060943 - An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds Phase 3
Completed NCT05612958 - Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds N/A
Completed NCT02672644 - Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep Phase 4
Completed NCT01012388 - Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color Phase 4
Completed NCT01635855 - Belotero Post Approval Study Phase 4
Completed NCT02179736 - A Post Market Evaluation After Treatment of Nasolabial Folds N/A
Terminated NCT00716443 - Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections Phase 4
Completed NCT00823069 - Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose N/A
Recruiting NCT06367634 - TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults N/A