HealthyPhase 1NCT01320761
A Study to Assess Injection Comfort of Two Formulations of ATX-101
A Phase 1 study testing ATX-101-BA-free and ATX-101-BA in people with Healthy, run by Kythera Biopharmaceuticals at 2 sites in United States.
Trial summary
To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATX-101-BA-free and ATX-101-BA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of submental fat graded by the investigator as 2, 3, or 4 using the CR-SMFRS (Appendix B).
- Sufficient and symmetrical submental fat such that the protocol-specified number of injections can be safely administered on both the right and left side.
- No difference in perception or sensitivity (pain or otherwise) between left and right sides of the submental area.
- Abstinence from alcohol for at least 6 hours prior to both the Baseline and 24-hour visits.
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on Baseline date.
- Females of child-bearing potential must have a negative urine human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial (including post-screening).
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- The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
- The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 14 days before dosing with study material for which the investigator identifies no clinically significant abnormality.
- Signed informed consent obtained before any study-specific procedure is conducted.
Who cannot join
- History of any intervention (e.g., liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect subject safety or other evaluations of treatment.
- Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
- Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
- Any cognitive impairment that, in the Investigator's opinion, would preclude study participation or compliance with protocol-specified procedures.
- Treatment with analgesics or other agents that could affect the pain response, including but not limited to acetaminophen or ibuprofen taken within 1 day prior to Baseline; additionally, narcotic analgesics, tranquilizers, hypnotics, sedatives, or opiates within 7 days prior to Baseline.
- Treatment of the chin or SMF with injectable steroids within 90 days prior to Baseline.
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- Participation in a pain study within 6 months prior to Baseline.
- History of chronic pain and/or a history of chronic analgesic or tranquilizer use within 90 days prior to Baseline.
- Any anticipated need for agents with anticoagulative effects (e.g., aspirin, ibuprofen, warfarin, heparin) during the course of the trial.
- Treatment with oral anticoagulants (e.g., aspirin, warfarin) within 10 days prior to Baseline.
- Treatment with topical agents to the submental or neck area, including but not limited to creams or ointments used to treat dermatologic conditions (e.g., steroids, capsaicin, retinoids, fluorouracil) within 7 days prior to Baseline.
- Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before dosing or botulinum toxin injections within 6 months prior to Baseline.
- Previous enrollment into this trial or treatment with ATX-101 or agents containing deoxycholate.
- Treatment with an investigational agent within 28 days prior to Baseline.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joel Schlessinger, M.D.
Omaha, Nebraska, 68144
Jeffrey M. Adelglass, M.D.
Plano, Texas, 75093
About this study
Official title: A Study to Assess Injection Comfort of Two Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Administration in the Submental Area
To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.
- Conditions
- Healthy
- Being tested
- ATX-101-BA-free, ATX-101-BA
- Keywords
- Formulation Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101-BA-freeDrug
ATX-101-BA-free
ATX-101-BADrug
ATX-101-BA
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | Left side injected first:
Left submental - ATX-101-BA Right submental - ATX-101-BA-free Receives: Drug: ATX-101-BA-free; Drug: ATX-101-BA |
| Group 1B | Experimental | Right side injected first:
Left submental - ATX-101-BA Right submental - ATX-101-BA-free Receives: Drug: ATX-101-BA-free; Drug: ATX-101-BA |
| Group 2A | Experimental | Left side injected first:
Left submental - ATX-101-BA-free Right submental - ATX-101-BA Receives: Drug: ATX-101-BA-free; Drug: ATX-101-BA |
| Group 2B | Experimental | Right side injected first:
Left submental - ATX-101-BA-free Right submental - ATX-101-BA Receives: Drug: ATX-101-BA-free; Drug: ATX-101-BA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort measure
The primary measure of comfort is the pain comparison scale between ATX-101-BA and ATX-101-BA-free at the time of injection using the pain comparison scale and the VAS pain rating scale.
Measured: up to 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patricia Walker, M.D., Study director, Kythera Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320761
- Sponsor's protocol ID
- ATX-101-10-19
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Injection Comfort of Two Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Administration in the Submental Area
- ClinicalTrials.gov ID
- NCT01320761
- Acronym / sponsor ID
- ATX-101-10-19
- Conditions
- Healthy
- Keywords
- Formulation Comparison
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 22 Mar 2011 (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.
To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Drug: ATX-101-BA-free, Drug: ATX-101-BALeft side injected first: Left submental - ATX-101-BA Right submental - ATX-101-BA-free |
| Group 1B | Experimental | Drug: ATX-101-BA-free, Drug: ATX-101-BARight side injected first: Left submental - ATX-101-BA Right submental - ATX-101-BA-free |
| Group 2A | Experimental | Drug: ATX-101-BA-free, Drug: ATX-101-BALeft side injected first: Left submental - ATX-101-BA-free Right submental - ATX-101-BA |
| Group 2B | Experimental | Drug: ATX-101-BA-free, Drug: ATX-101-BARight side injected first: Left submental - ATX-101-BA-free Right submental - ATX-101-BA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of submental fat graded by the investigator as 2, 3, or 4 using the CR-SMFRS (Appendix B).
- Sufficient and symmetrical submental fat such that the protocol-specified number of injections can be safely administered on both the right and left side.
- No difference in perception or sensitivity (pain or otherwise) between left and right sides of the submental area.
- Abstinence from alcohol for at least 6 hours prior to both the Baseline and 24-hour visits.
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on Baseline date.
Key exclusion criteria (14 listed)
- History of any intervention (e.g., liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect subject safety or other evaluations of treatment.
- Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
- Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
- Any cognitive impairment that, in the Investigator's opinion, would preclude study participation or compliance with protocol-specified procedures.
- Treatment with analgesics or other agents that could affect the pain response, including but not limited to acetaminophen or ibuprofen taken within 1 day prior to Baseline; additionally, narcotic analgesics, tranquilizers, hypnotics, sedatives, or opiates within 7 days prior to Baseline.
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 |
|---|---|---|
| ATX-101-BA-freeATX-101-BA-free | Drug | Group 1A, Group 1B, Group 2A, Group 2B |
| ATX-101-BAATX-101-BA | Drug | Group 1A, Group 1B, Group 2A, Group 2B |
Primary outcome
Comfort measure
Time frame: up to 24 hours after treatment
The primary measure of comfort is the pain comparison scale between ATX-101-BA and ATX-101-BA-free at the time of injection using the pain comparison scale and the VAS pain rating scale.
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 22 Mar 2011.
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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.
Patricia Walker, M.D. study director
Kythera Biopharmaceuticals, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATX-101-BA-free and ATX-101-BA in people with Healthy, run by Kythera Biopharmaceuticals at 2 sites 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 9 inclusion and 14 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 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Comfort measure (time frame: up to 24 hours after treatment). 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 22 Mar 2011.