Clinical trial NCT06457607: Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting
Official title: Prospective, Single Center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Intensity Focused Ultrasound
Keywords: High Intensity Focused Ultrasound
Lifting
Lead sponsor: Jeisys Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2024-06-13
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting

Detailed description: The goal of this open label study is to evaluate the efficacy and safety of treatment with HIFU system (LinearFirm(ULTRAcel Q+)) in temporary eyebrow lifting.

The target number of subjects for this clinical trial is set to 30 in a single group, without considering the statistical significance of hypothesis testing and dropout rate. Considering a dropout rate of 20%, the plan is to recruit a total of 38 subjects.

1. Evaluation of the effacacy is includes: Evaluation of eyebrow lifting photos by an independent evaluator, Patient Satisfaction (PS)
2. Evaluation of the safety is includes: Adverse events, vital signs, physical examination, and Visual Analogue Scale (VAS) after the application of medical devices for clinical trials

Eligibility criteria: Inclusion Criteria:

* 19 years old or older
* Voluntarily agreed to the clinical trial
* Who is need to eyebrow lifing

Exclusion Criteria:

* A history of cosmetic treatment (laser, light therapy, surgery, etc..) within the last 6 months
* A history of filler treatment (Collagen, AMA, etc...) within the last 6 months
* A history of Botulinum toxin injection within the last 6 months
* A history of treatment such as radiation therapy or chemotherapy, or history of malignat tumor
* A history of infections dermatitis, rash and shingles casued by thermal energy stimulation
* A history of treament with isotretinoin, retinoid preparations, or steroid preparations within the last 4 weeks
* Pregnancy
* Thos who participated in other clinical trials that affect the efficacy and safety evaluation of this clinical trial within 30 days of the screening date

Primary outcomes:
measure: The avegrage change in AEH (Average Eyebrow Height) and MEH(Maximum Eyebrow Height) compared to the Baseline
timeFrame: Base line and 4, 8, 12, 16weeks
measure: The evaluation of the GLS (Glabellar Line Scale) compared to the Baseline
timeFrame: Base line and 4, 8, 12, 16weeks
measure: The evaluation of the TEAE (Treatment Emergent Adverse Event) and serious AE/ADE
timeFrame: after 16weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Jeisys Medical Inc
name: Hye Jin Sun
role: STUDY_DIRECTOR
References: