ScarsNCT01810484

Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment

A study testing Ultherapy® treatment only, Ultherapy® treatment and CO2 laser treatment and CO2 Laser treatment only in people with Scars and Striae, run by Ulthera, Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Scars, Striae
What is being tested?: Ultherapy® treatment only, Ultherapy® treatment and CO2 laser treatment and CO2 Laser treatment only
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: Jan 2013to Jan 2015
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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female, aged 21 to 65 years.
Subject in good health.
Fitzpatrick skin classification type 1-5.
Striae rubra and alba on the abdomen.
Understands and accepts the obligation not to undergo any other procedures in the area(s) 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.

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Absence of physical or psychological conditions unacceptable to the investigator.
Willingness and ability to provide written consent for study-required photography and adherence to photography requirements .
Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control during the study

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Current bacterial or viral infection in the area to be treated.
Severe solar elastosis.
Significant scarring or burns in area(s) to be treated.
Prior radiation therapy in the area(s) to be treated.
Open wounds or lesions in the area(s) to be treated.

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History of keloid or hypertrophic scarring
History of irregular pigmentation of the skin, Lichens Planus, Vitiligo or Psoriasis in the treatment area that in the investigators opinion, would put the subject at unnecessary risk.
Inability to understand the protocol or to give informed consent.
Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within two weeks prior to study participation or during the study.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Subjects who, in the investigator's opinion, have a history of poor cooperation,noncompliance with medical treatment, or unreliability.
Concurrent enrollment in any study involving the use of investigational devices or drugs.
Current smoker or history of smoking in the last five years.
History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty.
History of prior Massive Weight Loss
History of using the following prescription medications:
Accutane or other systemic retinoids within the past 12 months;
Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 98207
Art Plastic Surgery
Paramus, New Jersey, 07652

Other trials in United States

About this study

Official title: Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae

Read the detailed description

This is a prospective, randomized, single-blinded, pilot clinical trial to evaluate the use of the Ulthera® System in combination with the 70W Alma Pixel CO2 laser for efficacious results in the treatment of abdominal striae rubra and striae alba. Subjects will be randomized to one of three treatment groups. Study personnel conducting efficacy measures will be blinded to the assigned treatment groups.

Changes from baseline in overall skin texture and appearance of abdominal striae will be assessed at study follow-up visits. 2D images, 3D images and patient satisfaction questionnaires will be obtained.

Conditions: Scars, Striae
Being tested: Ultherapy® treatment only, Ultherapy® treatment and CO2 laser treatment, CO2 Laser treatment only
Keywords: Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin
Medical subject headings: Cicatrix, Striae Distensae

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultherapy® treatment onlyDevice
Also called Ulthera® System treatment
Focused ultrasound energy delivered below the surface of the skin
Ultherapy® treatment and CO2 laser treatmentDevice
Also called Ulthera® System treatment, CO2 Fractional Ablative Laser teatment
Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
CO2 Laser treatment onlyDevice
Also called CO2 Fractional Ablative Laser teatment
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Study groups in NCT01810484
Study group	Role	What they receive
Group 1	Active comparator	The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment only; Treatment Area B will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area C will be treated with CO2 laser treatment only Receives: Device: Ultherapy® treatment only; Device: Ultherapy® treatment and CO2 laser treatment; Device: CO2 Laser treatment only
Group 2	Active comparator	The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area B will be treated with CO2 laser treatment only; Treatment Area C will be treated with Ultherapy® treatment only Receives: Device: Ultherapy® treatment only; Device: Ultherapy® treatment and CO2 laser treatment; Device: CO2 Laser treatment only
Group 3	Active comparator	The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with CO2 laser treatment only; Treatment Area B will be treated with Ultherapy® treatment only; Treatment Area C will be treated with Ultherapy® treatment and CO2 laser treatment Receives: Device: Ultherapy® treatment only; Device: Ultherapy® treatment and CO2 laser treatment; Device: CO2 Laser treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in overall skin texture and appearance of abdominal striae
A masked, qualitative assessment of change from baseline in the areas treated based a review of 2D images obtained at baseline and 90 days post-treatment.
Measured: 90-days post-treatment

Secondary outcomes (6)

90 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
Measured: 90 Days post-treatment
180 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
Measured: 180 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area
Measured: 90 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area
Measured: 180 Days post-treatment
Change from baseline in skin striae texture and depth at 90 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment.
Measured: 90 Days post-treatment
Change from baseline in skin striae texture and depth at 180 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment.
Measured: 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.

Jan 2013Jan 2015

First posted13 Mar 2013 (estimated)
Study startJan 2013
Primary completionNov 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ScarsStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01810484
Sponsor's protocol ID: ULT-133
Status last verified: Jan 2015
First submitted: 8 Mar 2013
Last updated: 31 Jan 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae
ClinicalTrials.gov ID: NCT01810484
Acronym / sponsor ID: ULT-133
Conditions: Scars, Striae
Keywords: Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Nov 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 13 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Active comparator	Device: Ultherapy® treatment only, Device: Ultherapy® treatment and CO2 laser treatment, Device: CO2 Laser treatment onlyThe abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment only; Treatment Area B will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area C will be treated with CO2 laser treatment only
Group 2	Active comparator	Device: Ultherapy® treatment only, Device: Ultherapy® treatment and CO2 laser treatment, Device: CO2 Laser treatment onlyThe abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area B will be treated with CO2 laser treatment only; Treatment Area C will be treated with Ultherapy® treatment only
Group 3	Active comparator	Device: Ultherapy® treatment only, Device: Ultherapy® treatment and CO2 laser treatment, Device: CO2 Laser treatment onlyThe abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with CO2 laser treatment only; Treatment Area B will be treated with Ultherapy® treatment only; Treatment Area C will be treated with Ultherapy® treatment and CO2 laser treatment

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female, aged 21 to 65 years.
Subject in good health.
Fitzpatrick skin classification type 1-5.
Striae rubra and alba on the abdomen.
Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.

Key exclusion criteria (23 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Current bacterial or viral infection in the area to be treated.
Severe solar elastosis.
Significant scarring or burns in area(s) to be treated.
Prior radiation therapy in the area(s) to be treated.

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
Ultherapy® treatment onlyAlso: Ulthera® System treatmentFocused ultrasound energy delivered below the surface of the skin	Device	Group 1, Group 2, Group 3
Ultherapy® treatment and CO2 laser treatmentAlso: Ulthera® System treatment, CO2 Fractional Ablative Laser teatmentUltherapy® treatment: Focused ultrasound energy delivered below the surface of the skin; CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.	Device	Group 1, Group 2, Group 3
CO2 Laser treatment onlyAlso: CO2 Fractional Ablative Laser teatmentCO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.	Device	Group 1, Group 2, Group 3

Primary outcome

Change from baseline in overall skin texture and appearance of abdominal striae
Time frame: 90-days post-treatment
A masked, qualitative assessment of change from baseline in the areas treated based a review of 2D images obtained at baseline and 90 days post-treatment.

6 secondary outcomes

90 Day Patient Satisfaction
Time frame: 90 Days post-treatment
180 Day Patient Satisfaction
Time frame: 180 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
Time frame: 90 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
Time frame: 180 Days post-treatment
Change from baseline in skin striae texture and depth at 90 Days
Time frame: 90 Days post-treatment
Change from baseline in skin striae texture and depth at 180 Days
Time frame: 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 31 Jan 2018.

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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.

Luis Zapiach, MD principal investigator

Art Plastic Surgery

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 23 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 31 Jan 2018. 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.

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?

Change from baseline in overall skin texture and appearance of abdominal striae (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?

On the ClinicalTrials.gov record for NCT01810484.

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 31 Jan 2018.