Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

NCT ID: NCT02607670

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TAT4 Gel

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

Group Type EXPERIMENTAL

TAT4 Gel

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

Interventions

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TAT4 Gel

Intervention Type DRUG

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Topokine Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Topokine Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael S Singer, MD, PhD

Role: CONTACT

Other Identifiers

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TAT4 B1

Identifier Type: -

Identifier Source: org_study_id

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