CompletedNot Applicable

Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients

United States60 participantsStarted 2017-08-10

Plain-language summary

To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Both parents of full Chinese decent.
✓. Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
✓. Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
✓. Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
✓. 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, 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:
✓. Postmenopausal with last menstrual bleeding at least 12 months prior to study; and
✓. Without a uterus and/or both ovaries.
✓. Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.

✕. Presence of an active systemic or local skin disease that may affect wound healing.
✕. Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
✕. Severe solar elastosis.
✕. Excessive subcutaneous fat in the area(s) to be treated.
✕. Excessive skin laxity on the area(s) to be treated.
✕. 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.

Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment

Timeframe: Baseline and Day 90

NCT IDNCT03351335

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-09

Results submitted2019-08-02

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Both parents of full Chinese decent.
✓. Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
✓. Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
✓. Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
✓. 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, 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:
✓. Postmenopausal with last menstrual bleeding at least 12 months prior to study; and
✓. Without a uterus and/or both ovaries.
✓. Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.

✕. Presence of an active systemic or local skin disease that may affect wound healing.
✕. Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
✕. Severe solar elastosis.
✕. Excessive subcutaneous fat in the area(s) to be treated.
✕. Excessive skin laxity on the area(s) to be treated.
✕. 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.