Skin LaxityNCT01708447
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
A study testing L.M.X.4.® cream and Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- L.M.X.4.® cream and Ulthera System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2012
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 30 to 65 years.
- Chosen an Ultherapy™ treatment as part of their treatment regimen.
- Subject in good health.
- Skin laxity on the face and neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Who cannot join
- Known sensitivity to lidocaine or any other anesthetic of the amide type.
- History of anaphylactic shock.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine).
- Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3).
- Severe solar elastosis.
Show all 13Show fewer
- Excessive subcutaneous fat in the face and neck.
- Body mass index of 30 or greater.
- Excessive skin laxity on the face and neck.
- Significant scarring in areas to be treated.
- Significant open facial wounds or lesions.
- Severe or cystic acne on the face.
- Presence of a metal stent or implant in the facial area to be treated.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Valley Plastic Surgery
Phoenix, Arizona, 85050
About this study
Official title: Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.
Read the detailed description
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
- Conditions
- Skin Laxity
- Being tested
- L.M.X.4.® cream, A placebo cream, Ulthera System Treatment
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L.M.X.4.® creamDrug
Also called A lidocaine topical anesthetic cream
A lidocaine topical anesthetic cream
A placebo creamOther
Placebo cream containing no anesthetic properties.
Ulthera System TreatmentDevice
Also called Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthetic - L.M.X.4.® cream | Active comparator | Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment. Receives: Drug: L.M.X.4.® cream; Device: Ulthera System Treatment |
| Placebo cream | Placebo comparator | A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment. Receives: Other: A placebo cream; Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related pain
The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.
Measured: During treatment
Secondary outcomes (1)
Improvement in skin laxity.
Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
Measured: 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Gitt, MD, Principal investigator, North Valley Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708447
- Sponsor's protocol ID
- ULT-117
- Status last verified
- Jun 2013
- First submitted
- 15 Oct 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment
- ClinicalTrials.gov ID
- NCT01708447
- Acronym / sponsor ID
- ULT-117
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Oct 2012 (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 evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.
Detailed description
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical anesthetic - L.M.X.4.® cream | Active comparator | Drug: L.M.X.4.® cream, Device: Ulthera System TreatmentTopical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment. |
| Placebo cream | Placebo comparator | Other: A placebo cream, Device: Ulthera System TreatmentA placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 30 to 65 years.
- Chosen an Ultherapy™ treatment as part of their treatment regimen.
- Subject in good health.
- Skin laxity on the face and neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period.
Key exclusion criteria (13 listed)
- Known sensitivity to lidocaine or any other anesthetic of the amide type.
- History of anaphylactic shock.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine).
- Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3).
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 |
|---|---|---|
| L.M.X.4.® creamAlso: A lidocaine topical anesthetic creamA lidocaine topical anesthetic cream | Drug | Topical anesthetic - L.M.X.4.® cream |
| A placebo creamPlacebo cream containing no anesthetic properties. | Other | Placebo cream |
| Ulthera System TreatmentAlso: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tighteningFocused ultrasound energy delivered below the surface of the skin | Device | Placebo cream, Topical anesthetic - L.M.X.4.® cream |
Primary outcome
Treatment-related pain
Time frame: During treatment
The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.
1 secondary outcome
Improvement in skin laxity.
Time frame: 90 days post-treatment
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 24 Nov 2017.
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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.
Steven Gitt, MD principal investigator
North Valley Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L.M.X.4.® cream and Ulthera System Treatment in people with Skin Laxity, run by Ulthera, 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 6 inclusion and 13 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 24 Nov 2017. 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.
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?
Treatment-related pain (time frame: During 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 24 Nov 2017.