Nasolabial FoldsPhase 1NCT02647853
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
A Phase 1 study testing TAT4 Gel concentration A and TAT4 Gel concentration B in people with Nasolabial Folds and Lipoatrophy, run by Topokine Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds, Lipoatrophy, Lipodystrophy
- What is being tested?
- TAT4 Gel concentration A and TAT4 Gel concentration B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 40-70 years old
- Healthy volunteers
- Provision of informed consent
Who cannot join
- History of skin hypersensitivity
- Abnormality on screening assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
- Conditions
- Nasolabial Folds, Lipoatrophy, Lipodystrophy
- Being tested
- TAT4 Gel concentration A, TAT4 Gel concentration B, Placebo
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAT4 Gel concentration ADrug
TAT4 Gel concentration BDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TAT4 Gel concentration A | Experimental | TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days. Receives: Drug: TAT4 Gel concentration A |
| TAT4 Gel concentration B | Experimental | TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days. Receives: Drug: TAT4 Gel concentration B |
| Placebo | Placebo comparator | Placebo product once daily to 50 cm2 for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event rates
Adverse event rates by System Organ Class, as graded by current CTCAE
Measured: 21 days
Secondary outcomes (3)
Plasma pharmacokinetics (Cmax)
Measured: Days 1 and 13
Plasma pharmacokinetics (Tmax)
Measured: Days 1 and 13
Plasma pharmacokinetics (AUC0-24)
Measured: Day 1 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647853
- Sponsor's protocol ID
- TAT4 A1
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2016
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
- ClinicalTrials.gov ID
- NCT02647853
- Acronym / sponsor ID
- TAT4 A1
- Conditions
- Nasolabial Folds, Lipoatrophy, Lipodystrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 2016 (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 Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAT4 Gel concentration A | Experimental | Drug: TAT4 Gel concentration ATAT4 Gel concentration A applied once daily to 50 cm2 for 14 days. |
| TAT4 Gel concentration B | Experimental | Drug: TAT4 Gel concentration BTAT4 Gel concentration B applied once daily to 50 cm2 for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo product once daily to 50 cm2 for 14 days. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 40-70 years old
- Healthy volunteers
- Provision of informed consent
Key exclusion criteria (2 listed)
- History of skin hypersensitivity
- Abnormality on screening assessments
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 concentration A | Drug | TAT4 Gel concentration A |
| TAT4 Gel concentration B | Drug | TAT4 Gel concentration B |
| Placebo | Drug | Placebo |
Primary outcome
Adverse Event rates
Time frame: 21 days
Adverse event rates by System Organ Class, as graded by current CTCAE
3 secondary outcomes
Plasma pharmacokinetics (Cmax)
Time frame: Days 1 and 13
Plasma pharmacokinetics (Tmax)
Time frame: Days 1 and 13
Plasma pharmacokinetics (AUC0-24)
Time frame: Day 1 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAT4 Gel concentration A and TAT4 Gel concentration B in people with Nasolabial Folds and Lipoatrophy, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event rates (time frame: 21 days). 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 6 Jan 2016.