Nasolabial FoldsPhase 2NCT02607670
Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds
A Phase 2 study testing TAT4 Gel in people with Nasolabial Folds, run by Topokine Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- TAT4 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe, bilateral nasolabial folds
- Must understand and provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Michael S Singer, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Topokine Research Site
Boston, Massachusetts
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds
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
- Being tested
- TAT4 Gel, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAT4 GelDrug
Matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| TAT4 Gel | Experimental | The participant will apply TAT4 Gel to the nasolabial fold area once daily. Receives: Drug: TAT4 Gel |
| Placebo | Placebo comparator | The participant will apply Placebo Gel to the nasolabial fold area once daily. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial Fold Severity Scale (Clinician-Reported)
Measured: Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607670
- Sponsor's protocol ID
- TAT4 B1
- Status last verified
- Jan 2016
- First submitted
- 16 Nov 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02607670
- Acronym / sponsor ID
- TAT4 B1
- Conditions
- Nasolabial Folds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAT4 Gel | Experimental | Drug: TAT4 GelThe participant will apply TAT4 Gel to the nasolabial fold area once daily. |
| Placebo | Placebo comparator | Drug: Matching placeboThe participant will apply Placebo Gel to the nasolabial fold area once daily. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderate to severe, bilateral nasolabial folds
- Must understand and provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAT4 Gel | Drug | TAT4 Gel |
| Matching placebo | Drug | Placebo |
Primary outcome
Nasolabial Fold Severity Scale (Clinician-Reported)
Time frame: Day 91
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Related trials for Nasolabial Folds
Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
Nasolabial Folds
Active, not recruiting
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Nasolabial Fold
RecruitingPhase 3
Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
Nasolabial Folds
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Singer, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAT4 Gel in people with Nasolabial Folds, run by Topokine Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael S Singer, MD, PhD (volunteers@topokine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial Fold Severity Scale (Clinician-Reported) (time frame: Day 91). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.