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Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02607670
Enrollment
111
Registered
2015-11-18
Start date
2016-01-31
Completion date
2016-09-30
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Folds

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.

Interventions

DRUGTAT4 Gel
DRUGMatching placebo

Sponsors

Topokine Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Nasolabial Fold Severity Scale (Clinician-Reported)Day 91

Countries

United States

Contacts

Primary ContactMichael S Singer, MD, PhD
volunteers@topokine.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026