A Single-Center, Single-arm, Open-label, Exploratory Study to Evaluate the Efficacy and Safety of Intradermal Injection of Hyaluronic Acid Filler
- Conditions
- Factors influencing health status and contact with health services
- Registration Number
- KCT0007664
- Lead Sponsor
- Hugel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
(1) Adult men and women between the ages of 30 and 60
(2) Those who show a decrease in skin elasticity when the cheek fold wrinkles are 2 or higher on the Lemperle wrinkle scale in the consultation with a dermatologist
(3) A person who can follow the procedures of clinical trials well and adhere to the visit schedule
(4) Those who agree to suspend all dermatological treatments or treatments, including facial wrinkle correction, during the clinical trial period
(5) Those who voluntarily agreed to participate in this clinical trial and provided written consent
(1) Those who have received filler or botulinum toxin treatment for 12 months before registration
(2) Those who have undergone facial wrinkle correction surgery (e.g., facelift, soft tissue augmentation, chemical dermabrasion, dermal photorejuvenation, laser treatment, etc.) within 6 months before participating in the clinical trial or are expected to receive it during the study period
(3) Those who have inflammatory and/or infectious diseases in the facial region that can affect clinical trials
(4) A person who has had a skin graft on the face
(5) Those who have had keloids or hyperproliferative wounds on the face
(6) Those who have had bleeding disorders in the past or present
(7) Aspirin administration is permitted for bleeding patients, those receiving anticoagulant treatment, or those who have taken antiplatelet or anticoagulant drugs 2 weeks prior (however, a low dose of 300mg/day or less).
(8) Those who have undergone autoimmune disease or immunotherapy
(9) Persons with a history of anaphylaxis or severe complex allergic symptoms
(10) Those who are allergic to or sensitive to clinical investigational drugs or their ingredients
(11) Pregnant, lactating, or pregnant women who do not consent to contraception by a medically acceptable method up to 8 weeks after administration of the drug
(12) Persons suffering from severe heart disease or respiratory disease
(13) Those who participated in other clinical trials within 4 weeks before participating in clinical trials and received clinical trial drugs or clinical trial equipment
(14) Others who are judged inappropriate for participation in this clinical trial by the person in charge of the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement rate of the measured value of skin wrinkle severity (Lemperle wrinkle scale) in the cheek area evaluated through clinical photographs
- Secondary Outcome Measures
Name Time Method Change in facial skin elasticity measured with a cutometer;Change in facial skin moisture content measured with a corneometer;Changes in facial transepidermal water loss (TEWL) measurements;Change in the glossiness of the facial skin surface measured with a Glossymeter;Change in facial skin moisture content measured by Moisture Map;Changes in facial skin roughness and pore size measured by PRIMOS;Changes in facial lifting as measured by the Morpheus system;Improvement rate according to the global aesthetic improvement scale (GAIS) evaluated on site by the investigator;Improvement rate according to the global aesthetic improvement scale (GAIS) evaluated by clinical trial subjects;Change in facial pore area measured with Antera 3D camera