Safety evaluation for quasi-drug use at HIFU treatment site for the facial sagging
- Conditions
- Sagging
- Registration Number
- JPRN-UMIN000052731
- Lead Sponsor
- POLA Chemical Industries,Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 24
Not provided
(1) Persons who have skin symptoms such as external wound, acne, eczema, etc. on the face (from the eyebrows to the chin) (2) Persons who have a history of surgery or injections (filler or metal) on the face (from eyebrows to chin tip) (3) Persons who have undergone cosmetic surgery in the past and are currently in the downtime period (4) Persons who have experienced severe pain, erythema, or scarring after undergoing cosmetic surgery in the past (5) Persons who have undergone cosmetic medical surgery (laser irradiation, photofacial, injection therapy, HIFU, incision, thread lift, etc.) that affect the shape and/or color tone of the face (6) Persons with a history of atopic dermatitis (7) Persons with allergies to disinfectant alcohol and/or rubber (8) Persons who are taking medicines (anticoagulants, etc.) that may affect the HIFU treatment (9) Persons who are pregnant, lactating, or planning to become pregnant during the study period (10) Persons who drink alcohol excessively on a regular basis (11) Persons who regularly go or plan to go to tanning salons or plan to do so during the study period (12) Persons who are expected to suffer from severe hay fever* during the study period (*level requiring a hospital visit) (13) Persons who are likely to be exposed to significant sunlight during the study period (e.g., Daily exercise during the daytime) (14) Persons with a history of serious hepatic disorder, renal disorder, or myocardial infarction (15) Persons with severe anemia (* Persons who have been to the hospital multiple times in the past due to anemia) (16) Persons receiving hormone replacement therapy (17) Persons who are currently participating in another clinical study or will participate in another clinical study during the study period (18) Persons with fever (*Exclusion criteria only on the day of the visit. Temperature will be taken at the reception desk) (19) Other persons deemed inappropriate by the research physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation for quasi-drugs use after HIFU: Difference in adverse events associated with the use of quasi-drugs in comparison between groups using quasi-drugs and groups using placebo
- Secondary Outcome Measures
Name Time Method Efficacy evaluation for quasi-drug use after HIFU treatment for improvement of sagging Regarding the following 4 parameters, the changes from the initial value will be evaluated. And, a group comparison between the quasi-drug use and placebo use will be conducted. 1. Assessment of IGA grade by dermatologist A dermatologist will evaluate the IGA grade of sagging. 2. Self-assessment by participants Participants themselves will evaluate the IGA grade of sagging. 3. Facial imaging analyses: Facial imaging analysis will be performed by VISIA and/or Vectra3D and calculate the sagging level.- 4. Self-assessment of skin sensation by participants Participants themselves will evaluate the skin sensation by questionnaires.