NCT02607670

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

November 16, 2015

Last Update Submit

January 2, 2016

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

  • Nasolabial Fold Severity Scale (Clinician-Reported)

    Day 91

Study Arms (2)

TAT4 Gel

EXPERIMENTAL

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

Drug: TAT4 Gel

Placebo

PLACEBO COMPARATOR

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

Drug: Matching placebo

Interventions

TAT4 GelDRUG
TAT4 Gel
Matching placeboDRUG
Placebo

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Moderate to severe, bilateral nasolabial folds
  • Must understand and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topokine Research Site

Boston, Massachusetts, United States

RECRUITING

Central Study Contacts

Michael S Singer, MD, PhD

CONTACT

volunteers@topokine.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

US(1)