Ultherapy® for the Treatment of Acne Scars

NCT02145364 | Completed

• 1 other identifier: ULT-139
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment.

Conditions

Acne Scars; Atrophic Acne Scars

Keywords

Ulthera System®; Ultherapy®; Ulthera, Inc.

Outcome Measures

Primary Outcomes (2)

• Acne Scar Improvement Scale

  Determined by a masked, qualitative assessment of photographs at 90 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.

  90 Days post-treatment #3

• Acne Scar Improvement Scale

  Determined by a masked, qualitative assessment of photographs at 180 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.

  180 days post-treatment #3

Secondary Outcomes (10)

• Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)

  60 days post-treatment #3

• Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)

  90 days post-treatment #3

• Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)

  180 days post-treatment #3

• Physician Acne Scar Assessment Scale

  60 days post-treatment #3

• Physician Acne Scar Assessment Scale

  90 days post-treatment #3

Study Arms (1)

Ultherapy® treatment of acne scars

EXPERIMENTAL

Subjects receiving dual depth treatment of acne scars using the 7MHz,3.0mm and 10MHz,1.5mm transducers.

Device: Ultherapy® treatment

Interventions

Ultherapy® treatment DEVICE

Microfocused ultrasound treatment

Also known as: Ulthera System®

Ultherapy® treatment of acne scars

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 to 70 years.
• Subject in good health.
• Presence of moderate to severe atrophic acne scars on the cheeks and/or temples.
• Scars must be rolling and boxcar type scars predominantly, with few to no icepick scars present.
• Scars should be distensible with tension applied to skin.
• Subject must desire correction of his/her acne scarring as demonstrated by any level of dissatisfaction on baseline PSQ.
• Subjects of all Fitzpatrick skin types are eligible.
• Subject must be willing to withhold additional aesthetic therapies in the areas to be treated for the entire study duration if these treatments are judged by the investigator to potentially impact results.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits
• Willingness to maintain current skin care regimen and refrain from adding any new products or drugs for acne or acne scars for the duration of the study.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
• 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 procedures.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Recent history of significant trauma to the face (\<6 months).
• Significant scarring, other than acne scars in area(s) to be treated.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic active and clinically significant acne on the area(s) to be treated.
• Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas.
• Have a history of systemic granulomatous diseases active or inactive or connective tissue disease.
• Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
• Presence of a metal stent or implant in the area(s) to be treated.
• Inability to understand protocol or give informed consent.
• Microdermabrasion or glycolic acid peels to the treatment area(s) within four weeks prior to study participation or during the study.
• History of allergic reaction to Ibuprofen, Acetaminophen, or Lidocaine/Tetracaine.
• History of chronic drug or alcohol abuse.
• History of autoimmune disease.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (2)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

The Maas Clinic

San Francisco, California, 94115, United States

Location

Study Officials

• John Joseph, MD

  Clinical Testing of Beverly Hills

  PRINCIPAL INVESTIGATOR

• Corey Maas, MD

  The Maas Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 14, 2017

Record last verified: 2015-10

Locations

US (2)