Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
1 other identifier
interventional
24
1 country
2
Brief Summary
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 24, 2017
December 1, 2014
2.8 years
April 27, 2012
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (4)
Change from baseline in skin clarity
180 days post-treatment
Reduction of sebum production
180 days post-treatment
Patient Satisfaction at 60 days
60 day post-treatment
Patient Satisfaction at 180 days
180 Days post-treatment
Study Arms (2)
Group A
ACTIVE COMPARATORUlthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.
Group B
ACTIVE COMPARATORUlthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.
Interventions
Focused ultrasound energy delivered below the surface of the skin.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulthera, Inclead
Study Sites (2)
Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, 91367, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Girish Munavalli, M.D.
Dermatology, Laser & Vein Specialists of the Carolinas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 3, 2012
Study Start
August 1, 2011
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
November 24, 2017
Record last verified: 2014-12