Sagging
Conditions
Interventions
HIFU and quasi-drug treatment group
HIFU and placebo treatment group
Sponsors
POLA Chemical Industries,Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Persons who have received an explanation of this research, understand the purpose of the research and the risks involved, and agree to participate in the research of their own free will (i.e., persons who have given their informed consent) (2) Persons with facial sagging (3) Healthy Japanese female ages 40 to 54 years old who do not meet the exclusion criteria (4) Persons who can fill out the consent form and other documents (5) Persons who can come to the designated facility on the day of the measurement (6) Persons who can answer the questionnaire about BMI and whose current BMI is between 18.5 and 25. (7) Persons who can bring their own cosmetics of facial wash and makeup on the day of the measurement.
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactFumiya Yamaji
POLA Chemical Industries, Inc. Frontier Research Center
Outcome results
None listed