Simulines Non-Inferiority Pivotal Study

Stopped early · Not applicable

Conditions studied: Skin Laxity

In brief

Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

Key facts

Study ID

NCT02736825

Run by

Ulthera, Inc

People needed

262

Starts

2016-04-11

Expected to finish

2017-04-25

Last updated by the study team

2020-02-19

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, age 30 to 70 years.
• Subject in good health.
• Body Mass Index (BMI) of ≤30.
• Skin laxity in the area(s) to be treated as determined by trained physician assessors.
• Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun lamps, or ultraviolet (UV) light sources.
• Willingness to apply study provided sunscreen (Neocutis Micro-Day Rejuvenating Cream) daily until study exit to help limit sun exposure.
• Willingness to avoid or periodically stop use of Sunless Tanners (washout period of two weeks prior to each study visit is required).
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
• Willingness to avoid non-emergent dental procedures in the 3 weeks prior to/ post treatment.
• 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.
• 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 (e.g. barrier methods used with a spermicidal agent, hormonal methods, intrauterine device (IUD), surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• a. Postmenopausal for at least 12 months prior to study; b. Without a uterus and/or both ovaries; or c. Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other non-steroidal anti-inflammatory drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the study treatment. After study treatment is completed, limited acute NSAID use, i.e., a maximum of 2-3 doses in any 2 week period, is allowed if needed.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• 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.
• History of Bell's Palsy.
• History of chronic or frequently recurring episodic (recurrent episode in past 12 months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy (such as biologic drug or corticosteroid treatment).
• Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the treatment area.
• History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw cysts.
• Known allergy or sensitivity to Ibuprofen.
• Severe solar elastosis.
• BMI > 30.
• Significant changes in weight (e.g. more than 5 pounds) over the past 6 months or anticipated significant changes in weight or diet over the course of the study.
• Pregnant within the past year.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity in the area(s) to be treated as determined by trained physician assessors.
• Significant scarring in the area(s) to be treated that would interfere with assessing results.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included).
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• History of chronic drug or alcohol abuse.
• 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.

Where it is running

• Clinical Testing of Beverly Hills — Beverly Hills, California, United States
• Roseville Facial Plastic Surgery — Roseville, California, United States
• Laser and Skin Surgery Center — Sacramento, California, United States
• Dermatology Cosmetic Laser Medical Associates of La Jolla — San Diego, California, United States
• AboutSkin Dermatology — Greenwood Village, Colorado, United States
• Maryland Laser Skin and Vein Dermatology — Cockeysville, Maryland, United States
• Wilmington Dermatology Center — Wilmington, North Carolina, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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