Skin Laxity of the décolletéNCT01485107
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
A study testing Ulthera® System in people with Skin Laxity of the décolleté, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity of the décolleté
- What is being tested?
- Ulthera® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 35 to 60 years.
- Subject in good health.
- Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up 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
- Presence of an active systemic or local skin disease that may affect wound healing.
- Scarring in areas to be treated.
- Tattoos in the areas to be treated.
- Patients with ports or defibrillators.
- Breast size >400cc each as measured by water displacement method.
- History of breast reduction surgery.
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- Any open wounds or lesions in the area.
- Active and severe inflammatory acne in the region to be treated.
- Patients who have a history with keloid formation or hypertropic scarring
Trial locations and contacts
1 site in 1 country.
United States1 site
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
San Diego, California, 92121
About this study
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
Read the detailed description
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
- Conditions
- Skin Laxity of the décolleté
- Being tested
- Ulthera® System
- Keywords
- Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera® SystemDevice
Also called Ultherapy™ treatment
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Ultherapy™ treatment on the décolleté | Experimental | All enrolled subjects will receive the study treatment. Receives: Device: Ulthera® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall lifting and tightening of skin
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
Measured: 90 days post-treatment
Secondary outcomes (4)
Skin Laxity of the Décolleté
The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.
Measured: 90 and 180 days post-treatment
Bilateral chest measurements
Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.
Measured: 90 and 180 days post-treatment
Overall aesthetic improvement
Based on Global Aesthetic Improvement Scale (GAIS) scores.
Measured: 90 and 180 days post-treatment
Patient satisfaction
Subject-completed questionnaire.
Measured: 90 and 180 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 posted5 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Laxity of the décolletéStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Goldman, MD, Principal investigator, Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485107
- Sponsor's protocol ID
- ULT-105
- Status last verified
- Jun 2013
- First submitted
- 1 Dec 2011
- 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 Ulthera® System for Lifting and Tightening of the Décolleté
- ClinicalTrials.gov ID
- NCT01485107
- Acronym / sponsor ID
- ULT-105
- Conditions
- Skin Laxity of the décolleté
- Keywords
- Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Dec 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.
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
Detailed description
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultherapy™ treatment on the décolleté | Experimental | Device: Ulthera® SystemAll enrolled subjects will receive the study treatment. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, aged 35 to 60 years.
- Subject in good health.
- Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up 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.
Key exclusion criteria (9 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Scarring in areas to be treated.
- Tattoos in the areas to be treated.
- Patients with ports or defibrillators.
- Breast size >400cc each as measured by water displacement method.
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 |
|---|---|---|
| Ulthera® SystemAlso: Ultherapy™ treatmentFocused ultrasound energy delivered below the surface of the skin. | Device | Ultherapy™ treatment on the décolleté |
Primary outcome
Improvement in overall lifting and tightening of skin
Time frame: 90 days post-treatment
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
4 secondary outcomes
Skin Laxity of the Décolleté
Time frame: 90 and 180 days post-treatment
Bilateral chest measurements
Time frame: 90 and 180 days post-treatment
Overall aesthetic improvement
Time frame: 90 and 180 days post-treatment
Patient satisfaction
Time frame: 90 and 180 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.
Related trials for Skin Laxity of the décolleté
Not yet recruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
Skin Aging, Wrinkles in Decolletage
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 Goldman, MD principal investigator
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera® System in people with Skin Laxity of the décolleté, 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 5 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?
Improvement in overall lifting and tightening of skin (time frame: 90 days post-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.