Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

Topokine Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Nasolabial Folds

Treatments: Drug: TAT4 Gel; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607670

TAT4 B1

Details and patient eligibility

About

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

Enrollment: 111 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 2 patient groups, including a placebo group

TAT4 Gel

Experimental group

Description:

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

Treatment:

Drug: TAT4 Gel

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Matching placebo