Excess Submental Fat ("Double Chin")Phase 2NCT01990326
Safety and Feasibility Study of XAF5 Gel for Reduction of Submental Fat
A Phase 2 study testing XAF5 Gel in people with Excess Submental Fat ("Double Chin"), run by Topokine Therapeutics, Inc..
Trial summary
This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excess Submental Fat ("Double Chin")
- What is being tested?
- XAF5 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women
- Must understand and provide informed consent
- Moderate submental fat (as determined by the clinician)
- No laxity (looseness) or minimal laxity of submental skin
- Healthy skin upon which a skin reaction would be visible
Who cannot join
- A clinically significant health problem or recent illness
- A clinically significant abnormal result on physical exam or laboratory tests
- Neck or facial hair that would interfere with applying the study drug to submental skin
- Clinically significant skin disease
- Body Mass Index (BMI) >= 40
- Plan to begin a diet or weight loss regimen during the study
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of XAF5 Gel for Reduction of Submental Fat
This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.
- Conditions
- Excess Submental Fat ("Double Chin")
- Being tested
- XAF5 Gel, Placebo Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XAF5 GelDrug
Placebo GelDrug
| Study group | Role | What they receive |
|---|---|---|
| XAF5 Gel | Experimental | The patient will apply XAF5 Gel to the skin of the submental area once a night. Receives: Drug: XAF5 Gel |
| Placebo Gel | Placebo comparator | The patient will apply a Placebo Gel to the skin of the submental area once a night. Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: From Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
Why it stopped: Feasibility cohorts competed. Efficacy cohort not initiated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excess Submental Fat ("Double Chin")Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael S Singer, M.D., Ph.D., Study director, Topokine Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990326
- Sponsor's protocol ID
- XAF5 B1
- Status last verified
- Jul 2014
- First submitted
- 1 Nov 2013
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of XAF5 Gel for Reduction of Submental Fat
- ClinicalTrials.gov ID
- NCT01990326
- Acronym / sponsor ID
- XAF5 B1
- Conditions
- Excess Submental Fat ("Double Chin")
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Feasibility cohorts competed. Efficacy cohort not initiated for business reasons
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 21 Nov 2013 (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 study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XAF5 Gel | Experimental | Drug: XAF5 GelThe patient will apply XAF5 Gel to the skin of the submental area once a night. |
| Placebo Gel | Placebo comparator | Drug: Placebo GelThe patient will apply a Placebo Gel to the skin of the submental area once a night. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men and women
- Must understand and provide informed consent
- Moderate submental fat (as determined by the clinician)
- No laxity (looseness) or minimal laxity of submental skin
- Healthy skin upon which a skin reaction would be visible
Key exclusion criteria (6 listed)
- A clinically significant health problem or recent illness
- A clinically significant abnormal result on physical exam or laboratory tests
- Neck or facial hair that would interfere with applying the study drug to submental skin
- Clinically significant skin disease
- Body Mass Index (BMI) >= 40
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 |
|---|---|---|
| XAF5 Gel | Drug | XAF5 Gel |
| Placebo Gel | Drug | Placebo Gel |
Primary outcome
Frequency of adverse events
Time frame: From Day 1 to Day 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
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, M.D., Ph.D. study director
Topokine Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XAF5 Gel in people with Excess Submental Fat ("Double Chin"), run by Topokine Therapeutics, Inc..
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 5 inclusion and 6 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: paused, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Frequency of adverse events (time frame: From Day 1 to Day 57). 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 29 Feb 2016.