KCT0006956招募中未知
Multi-center, Randomized, Subject & Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HyaFilia ME:DAM Prime PLUS as Compared to RESTYLANE Lidocaine in temporary Correction of Nasolabial folds
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male and female over the age of 19 years
- •2. Among those wanting temporary improvement of nasolabial folds on both sides, those with Wrinkle Severity Rating Scale (WSRS) or 3 or 4 points (it is not necessary for both sides to have the same score).
- •3. Those who consented to discontinue all dermatological measures or treatments including facial wrinkle improvement (filler, Botulium toxin, laser therapy, chemical exfoliation and surgery for cosmetic purpose, etc.) other than the medical device for clinical trial during the period thereof.
- •4. Those capable of understanding and complying with the instructions, and participation throughout the entire clinical trial period.
- •5. Those who voluntarily decided to participate in this clinical trial and signed informed consent as the subjects.
排除标准
- •1. Those administered with antithrombotic agent (excluding low-dose aspirin (100 mg with maximum of 300 mg/day)), vitamin E and NSAID agent for the period from 2 weeks prior to and 2 weeks after the application of the medical device for clinical trial.
- •2. Those with past history of bleeding disorder in the past or at the present.
- •3. Those who underwent CaHA (Calcium Hydroxyapatite) or PLLA (Poly L-Lactide) filler treatment at the area of the application of medical device for clinical trial within the last 1 year from the date of screening for this clinical trial.
- •4. Those who used locally applied drug (steroid and retinoid: corresponds only to medical drug with exclusion of cosmetics) on the face within 4 weeks of the screening date or scheduled to use such drug during the clinical trial period (however, steroid ointment can be used for short period within 14 successive days if for therapeutic purpose).
- •5. Those who used immune suppressant, chemical therapy agent or systemic corticosteroid within 12 weeks of the screening date.
- •6. Those who underwent treatment for wrinkle improvement or acne scars within 24 weeks of the screening date.
- •7. Those who underwent facial exfoliation, skin regeneration or plastic surgery (including Botulium toxin injection) within 24 weeks of the screening date.
- •8. Those who inserted permanent skin expansion prosthesis such as softening gel (Softform) or silicon in the face.
- •9. Those with skin disorder or infection of wound in the face that would affect this clinical trial.
- •10. Those with autoimmune disorder or past history thereof, or degraded immunity.
- •11. Those who are hypersensitive to hyaluronic acid
- •12. Patients with a history of streptococcal disease
- •13. Those with past history of manifestation of anaphylaxis or severe complex allergy symptoms.
- •14. Those with past history of hypertrophic scar or keloidal disorder.
- •15. Patients with hypersensitivity to lidocaine or other amide range of local anesthetics.
- •16. Those who previous had or currently have mental disorder that could have significant effects on this clinical trial, or display clinically serious disorders in cardiovascular, digestive, respiratory, endocrine and central nervous systems.
- •17. Those who have participated in other clinical trial within 30 days of the screening date and were administered/applied with medical drug/medical device for such clinical trial.
- •18. Among female subjects with possibility of pregnancy, those who have not consented to birth control* in the medically approved method up to 48 weeks following the application of medical device in this clinical trial.
- •* Medically approved birth control method: Condom, oral birth control method used for 3 months at the minimum, using birth control agent that is injected or inserted, and installation of birth control device inside uterus, etc.
- •19. Pregnant or breast-feeding women
- •20. Those other than above for whom the personnel responsible or in charge of the clinical trial gave clinically significant opinion based on medical determination that the subject is not appropriate for this clinical trial.
研究者
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