ISRCTN17960592进行中（未招募）未知
A Post Market Clinical Follow Up (PMCF) Study to Assess the Safety and Efficacy of MaiLi Volume and MaiLi Extreme in the Treatment of Temporal Hollowing, Mid-Face Volume Deficit, Jawline Ptosis, and Chin Retrusion
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects must be generally healthy and 25-65 years of age at Screening Visit
- •2. Subjects who have:
- •2.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale)
- •2.2. Mild to moderate jawline ptosis (score of 1-2 on the designated photographic assessment scale)
- •2.3. Minimal to severe chin retrusion (score of 1-3 on the designated photographic assessment scale)
- •2.4. Minimal to severe temporal hollowing (score if 2-4 on the designated photographic assessment scale)
- •3. Subjects who are willing to provide written informed consent, including approval for facial photographs to be taken.
- •4. Subjects willing to commit to having no further facial aesthetic treatments (see Table 2), that could affect the appearance of the facial treatment area, for the duration of the study period, including follow-up.
- •5. 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.
- •6. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •1. Subjects who, in the twelve months prior to their enrolment assessment had undergone:
- •1.1. cosmetic facial plastic surgery (other than rhinoplasty),
- •1.2. tissue grafting (e.g., fat injections),
- •1.3. tissue lifting implants (e.g., threads, barbs) or other implants,
- •1.4. augmentation with any permanent or semi-permanent filler (e.g., silicone, PMMA, PLLA) or temporary filler (e.g., Ha, CaHA, PCL)
- •1.5. neuromodulator injections,
- •1.6. mesotherapy,
- •1.7. resurfacing in the mid-face (e.g., laser, radio frequency, dermabrasion, or chemical peel)
- •in the region of the face to be treated.
- •2. Subjects who have received other facial aesthetic procedures, that affects the appearance of the facial treatment, at any time during the study period.
- •3. Subjects currently enrolled in other clinical trials.
- •4. Subjects with facial hair as this could interfere with study evaluations.
- •5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •6. Subject is an employee of the aesthetic surgery department on the investigational site, the CRO or study sponsor.
- •7. Pregnant or nursing woman or planning a pregnancy during the study.
- •8. Subjects taking thrombolytics or anticoagulants.
- •9. Subjects with bleeding disorders.
- •10. Subjects with known hypersensitivities to hyaluronic acid, lidocaine, amide local anaesthetics or other components of the treatment.
- •11. Subjects with a history of severe allergy or anaphylactic shock.
- •12. Subjects with active (or a history of) autoimmune disease.
- •13. Subjects with porphyria.
- •14. Subjects with cutaneous disorders and areas affected by inflammation and/or infectious skin problems (e.g., acne, herpes) at or near the treatment site.
- •15. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders.
- •16. Subject with known history of precancerous lesions/skin malignancies.
- •17. Subjects must avoid receiving COVID-19 vaccination for the 14 days before and following injection.
研究者
相似试验
进行中（未招募）
3 期
A post-market clinical follow-up study of Perfectha Subskin LidocaineA range of Fitzpatrick skin types presenting significant loss of volume in the cheeks, jawline and/or chinSkin and Connective Tissue DiseasesISRCTN63865080Sinclair Pharma69
招募中
4 期
To study the effectiveness of surgical treatment in patients with knee joint paiCTRI/2023/12/060753Auxein Medical Pvt Ltd
已完成
不适用
Post-market clinical follow-up (PMCF) study to investigate the percentage of relapses in treatment with KadeFungin® Milchsäurekur and its tolerability in female patients suffering from recurrent urinary tract infectioN39.0N30.2Urinary tract infection, site not specifiedOther chronic cystitisDRKS00016760DR. KADE Pharmazeutische Fabrik GmbH81
已完成
不适用
Post-Market Clinical Follow-up (PMCF) Study with the MOBIS II ST cage-implant for transforaminal lumbar fusion (TLIF)Diseases of the lumbar spine (L1-S1) like degenerative disc diseases, mechanical instability and osteochondrosis.M42.16M43.16M43.17M47.26M48.06M51.2M51.3M53.26M47.17Other specified intervertebral disc displacementOther specified intervertebral disc degenerationDRKS00020523SIGNUS Medizintechnik GmbH57
已完成
不适用
Post-market clinical follow-up (PMCF) study to observe the course of symptoms of vulvovaginal dryness in patients receiving therapy with KadeFungin® BefeuchtungsgelN89.8Other specified noninflammatory disorders of vaginaDRKS00017248DR. KADE Pharmazeutische Fabrik GmbH100