A Single-center, Randomnized, Evaluator-blinded, Active-controlled Study to evaluate the effectiveness and Safety of Neuramis deep for Correct in Patients with lip and perioral wrinkles.
Phase 1
- Conditions
- Male and Female age 20 years or older with perioral wrinkle severity scale (PWSS) of moderate to severePerioral wrinkle
- Registration Number
- TCTR20231008002
- Lead Sponsor
- Medyceles Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Male and Female age 20 years old or older
2. Perioral wrinkle severity scale (PWSS) of moderate to severe level
3. Consent in participate in the project
Exclusion Criteria
1. Previous laser treatment 6 months prior
2. Previous mesotherapy treatment 3 months prior
3. Previous botulinum toxin 6 months prior
4. Previous biostimulator injection 3 months prior
5. History of allergy to anesthesia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PWSS 3 months PWSS score measurement
- Secondary Outcome Measures
Name Time Method PWSS 1 month PWSS score measurement ,PWSS 2 months PWSS score measurement ,GAIS 1, 2, 3, 6 months GAIS measurement by physician,Wrinkle and Texture 0, 1, 2, 3, 6 months Antera,Volume change 0, 1, 2, 3, 6 months Vectra program