Recruiting
Phase 2

TAT4 Gel

Sponsor:

Topokine Therapeutics, Inc.

Code:

NCT02607670

Conditions

Nasolabial Folds

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Not accepted

Interventions

TAT4 Gel

Matching placebo

Study Details

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.

Conditions

Nasolabial Folds

Study ID

NCT02607670

Start date

Jan, 2016

Status verified date

Jan, 2016

Completion date

Sep, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 60

Healthy Volunteers: Not accepted

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

Enrollment

111 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAT4 Gel

The participant will apply TAT4 Gel to the nasolabial fold area once daily.

placebo comparator: Placebo

The participant will apply Placebo Gel to the nasolabial fold area once daily.

Interventions

TAT4 Gel

Matching placebo

Primary outcome measure

  • Nasolabial Fold Severity Scale (Clinician-Reported) [ Time Frame: Day 91 ]

Central Contacts and Locations

Central contacts

Michael S Singer, MD, PhD

volunteers@topokine.com

Locations

Topokine Research Site

Recruiting

Boston, Massachusetts, United States

More Information

Sponsor

Topokine Therapeutics, Inc.

Last update posted

Jan 5, 2016

Last verified

Jan, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Topokine Therapeutics, Inc. on 2016-01-05.