Skin LaxityNCT01708473
Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
A study testing Advil, Lortab and Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
This study will compare the effectiveness of two pain medications for reducing discomfort during an 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?
- Advil, Lortab and Ulthera System Treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 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
- Subject in good health
- Skin laxity on the upper and lower face and neck
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
Who cannot join
- Known sensitivity to ibuprofen, acetaminophen, or opiates
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat in the face and neck
- Excessive skin laxity on the face and neck
- Significant scarring in areas to be treated
Show all 9Show fewer
- 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
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, 20852
About this study
Official title: Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment
This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.
Read the detailed description
This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.
- Conditions
- Skin Laxity
- Being tested
- Advil, Lortab, 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.
AdvilDrug
One (1) tablet 800 mg Advil one hour prior to treatment.
LortabDrug
One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
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 |
|---|---|---|
| Advil with Ultherapy | Active comparator | Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment. Receives: Drug: Advil; Device: Ulthera System Treatment |
| Lortab with Ultherapy | Active comparator | Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment. Receives: Drug: Lortab; Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment discomfort
The validated NRS scale will be used to measure average pain scores reported by subject during treatment.
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 following 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 completionFeb 2012
- Study completionFeb 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hema Sundaram, MD, Principal investigator, Dermatology, Cosmetic & Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708473
- Sponsor's protocol ID
- ULT-123
- 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: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment
- ClinicalTrials.gov ID
- NCT01708473
- Acronym / sponsor ID
- ULT-123
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 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 compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.
Detailed description
This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advil with Ultherapy | Active comparator | Drug: Advil, Device: Ulthera System TreatmentSubjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment. |
| Lortab with Ultherapy | Active comparator | Drug: Lortab, Device: Ulthera System TreatmentSubjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 30 to 65 years
- Subject in good health
- Skin laxity on the upper and lower 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 (9 listed)
- Known sensitivity to ibuprofen, acetaminophen, or opiates
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat in the face and neck
- Excessive skin laxity on the face and neck
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 |
|---|---|---|
| AdvilOne (1) tablet 800 mg Advil one hour prior to treatment. | Drug | Advil with Ultherapy |
| LortabOne (1) tablet 10/500 mg of Lortab one hour prior to treatment. | Drug | Lortab with Ultherapy |
| Ulthera System TreatmentAlso: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tighteningFocused ultrasound energy delivered below the surface of the skin | Device | Advil with Ultherapy, Lortab with Ultherapy |
Primary outcome
Treatment discomfort
Time frame: During treatment
The validated NRS scale will be used to measure average pain scores reported by subject during treatment.
1 secondary outcome
Improvement in skin laxity
Time frame: 90 days following 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.
Hema Sundaram, MD principal investigator
Dermatology, Cosmetic & Laser 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 Advil, Lortab 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 4 inclusion and 9 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. 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 discomfort (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.