Feasibility Study: Ulthera® System for the Treatment of M... | NCT01591304

Studies
Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne

NCT01591304

Sponsor

Ulthera, Inc

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Facial Acne

Interventions

Ulthera System Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

May 2, 2012

First Posted Date

May 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2017

Last Update Posted Date

Nov 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.

Detailed Description

Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.

For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.

Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.	Device: Ulthera System Treatment
Group B	Active Comparator	Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.	Device: Ulthera System Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ulthera System Treatment	Device	Focused ultrasound energy delivered below the surface of the skin.	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in facial acne	Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.	60 days post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in skin clarity	Measured using a digital imaging system comparing baseline and post-treatment images.	180 days post-treatment
Reduction of sebum production	Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged 18 years and older.
Subject in good health.
Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.

Exclusion Criteria:

Presence of >2 nodular lesions in the areas to be treated.
Presence of any cysts in the areas to be treated.
Presence of an active systemic or local skin disease that may affect wound healing.
Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
History of keloid scar formation.
Significant scarring in areas to be treated.
Significant open facial wounds or lesions.
Presence of a metal stent or implant in the facial area to be treated.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Girish Munavalli, M.D.	Dermatology, Laser & Vein Specialists of the Carolinas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multispecialty Aesthetic Clinical Research Organization		Woodland Hills	California	91367	United States