DRKS00029739已完成未知
Assessment of the Efficacy and Safety of the Use of Perfectha Deep Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines and Temple Hollowing - LINAMATE
Sinclair Pharmaceuticals LtdEden HouseLakeside0 个研究点目标入组 70 人开始时间: 2022年10月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 25 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Male or female subjects between the ages of 25 and 65 years of age
- •2. Subject seeking an aesthetic improvement of her/his face with a hyaluronic acid dermal filler product
- •3. Any one or more of the following clinician-assessed criteria:
- •- moderate to severe nasolabial folds (3-4 on the WSRS scale)
- •- moderately deep to very long and deep marionette lines (2-3 on the Marionette lines grading scale)
- •- minimal to severe temporal hollowing (2-4 on the temple hollowing scale)
- •4. Subject having given freely and expressly his/her informed consent.
- •5. Subject willing to have photographs of the face taken and who is willing to provide approval for the use of their study data including photographs
- •6. Subjects must be willing and able to comply with protocol requirements, instructions, and protocol-stated restrictions and be likely to complete the study as planned.
- •7. Women of childbearing potential should be using a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and over the entire study duration.
- •8. Subjects willing to commit to having no further facial aesthetic treatments that will affect the appearance of the study treatment areas for the duration of the study period, including follow-up
排除标准
- •1. Subjects meeting any of the following criteria will be excluded from the study: Subjects who, in the twelve months prior to their enrolment assessment had undergone:
- •- cosmetic facial plastic surgery (other than rhinoplasty),
- •- tissue grafting (e.g., fat injections),
- •- tissue lifting implants (e.g., threads, barbs) or other implants,
- •- augmentation with any permanent or semi-permanent filler (e.g., silicone, PMMA, PLLA) or temporary filler (e.g., Ha, CaHA, PCL)
- •- neuromodulator injections,
- •- mesotherapy,
- •- resurfacing (e.g., laser, radio frequency, derm-abrasion, or chemical peel)
- •in the facial region to be treated.
- •2. Subjects who have received any other facial aesthetic procedures that will affect the appearance in the region of the face to be treated, at any time during the study period.
- •3. Pregnant women or nursing women or women planning to become pregnant during the study.
- •4. Subject, who is likely to become pregnant during the course of the study, who is not using or has changed or started their medically accepted contraceptive regimen or any other hormonal treatment during the 12 weeks prior to study entry.
- •5. Subject with known history of, or susceptibility to, keloid formation or hypertrophic scarring.
- •6. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety
- •7. Subject with scar(s), mole(s), tattoos, permanent make-up, facial hair, or anything in the studied zones which might interfere with the evaluation.
- •8. Subject with known history of or suffering from autoimmune disease and/or immune deficiency
- •9. Subject with porphyria.
- •10. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta blockers)
- •11. Subject with epilepsy not controlled by treatment.
- •12. Subject with known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement).
- •13. Subject with known history of precancerous lesions/skin malignancies.
- •14. Subject with known history of severe allergy or anaphylactic shock
- •15. Subject with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.
- •16. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment.
- •17. Subject suffering from active disease such as inflammation, infection, tumors, psoriasis, allergic edema, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea...…) on the face within 6 months of the study entry.
- •18. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety.
- •19. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety.
- •20. Subjects with a medical history showing sensitivity for reacting to the treatment
- •21. Subject with major dental problems or subject who received oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks prior to study entry.
- •22. Known allergies to product ingredients (Lidocaine or amide-type local anesthetics) or avian proteins, feathers and egg products (hyaluronic acid).
- •23. Subject is in institutional care.
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