Clinical trial NCT02145364: Ultherapy® for the Treatment of Acne Scars
Official title: Evaluation of the Ulthera® System for Correction of Moderate to Severe Atrophic Acne Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars
Atrophic Acne Scars
Keywords: Ulthera System®
Ultherapy®
Ulthera, Inc.
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive up to three dual-depth treatments to the cheek and temple areas impacted by acne scars, treating the number of treatment squares necessary to cover the area of scarring. Each treatment square will receive 30 lines per transducer depth for a total of 60 lines per treatment square. Three treatments 30 days apart will be required.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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, or participated within the past 30 days, in any study involving the use of investigational devices or drugs.
* Current smoker or history of smoking in the last two years.
* History of the following cosmetic treatments in the areas to be treated:

  1. Skin tightening procedure within the past year;
  2. Injectable filler of any type within the past: i. 12 months for Hyaluronic acid fillers (e.g.,Restylane); ii. 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse); iii. 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra); iv. Cultured fibroblast (e.g. LaViv) within the past two years; v. Ever for permanent fillers (e.g., Silicone, ArteFill)
  3. Neurotoxins within the past three months;
  4. Ablative resurfacing laser treatment within the past two years;
  5. Nonablative, rejuvenative laser or light treatment within the past six months;
  6. Surgical dermabrasion or deep facial peels within the past two years;
  7. Any history of contour threads.
* History of using the following prescription medications

  1. Accutane or other systemic retinoids within the past six months;
  2. Topical retinoids within the past two weeks;
  3. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use);
  4. Aspirin greater than 82mg/day
  5. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent or affect their ability to accurately complete QOL and subjective improvement assessments.
* Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol.

Primary outcomes:
measure: Acne Scar Improvement Scale
timeFrame: 90 Days post-treatment #3
measure: Acne Scar Improvement Scale
timeFrame: 180 days post-treatment #3
Secondary outcomes:
measure: Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
timeFrame: 60 days post-treatment #3
measure: Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
timeFrame: 90 days post-treatment #3
measure: Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
timeFrame: 180 days post-treatment #3
measure: Physician Acne Scar Assessment Scale
timeFrame: 60 days post-treatment #3
measure: Physician Acne Scar Assessment Scale
timeFrame: 90 days post-treatment #3
measure: Physician Acne Scar Assessment Scale
timeFrame: 180 days post-treatment #3
measure: Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
timeFrame: 60 days post-treatment #3
measure: Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
timeFrame: 90 days post-treatment #3
measure: Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
timeFrame: 180 days post-treatment #3
measure: Patient Satisfaction Questionnaire (PSQ)
timeFrame: 90 days post-treatment #3
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Clinical Testing of Beverly Hills
state: California
city: San Francisco
country: United States
facility: The Maas Clinic
state: California
Study officials:
affiliation: Clinical Testing of Beverly Hills
name: John Joseph, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Maas Clinic
name: Corey Maas, MD
role: PRINCIPAL_INVESTIGATOR
References: