ISRCTN63865080进行中（未招募）3 期
A post market clinical follow up (PMCF) study to assess the safety and efficacy of use of Perfectha Subskin Lidocaine in the treatment of significant loss of volume in the cheeks, jawline and/or chin
Sinclair Pharma0 个研究点目标入组 69 人开始时间: 2022年11月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
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 between 25 and 65 years of age.
- •2. Subjects seeking an aesthetic improvement of volume loss in his/her cheeks, jawline and/or chin with hyaluronic acid dermal filler
- •3. Subjects who present significant loss of volume in the cheeks, jawline and/or chin as assessed by a suitable recognised photographic scale:
- •3.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale, or
- •3.2. Mild to moderate jawline ptosis (score of 1-2 on the designated photographic assessment scale, or
- •3.3. Minimal to severe chin retrusion (score of 1-3 on the designated photographic assessment scale
- •4. Subjects who are willing to provide written informed consent, including approval for facial photographs to be taken.
- •5. Subjects willing to commit to having no further facial aesthetic treatments, that could affect the appearance of the facial treatment area, for the duration of the study period, including follow-up.
- •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. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the entire study.
排除标准
- •1. Subjects who, in the twelve months prior to their enrolment assessment have 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 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 a treatment with a permanent filler (e.g. silicone, PMMA, PLLA) in the region of the face to be treated.
- •3. Subjects who have received other facial aesthetic procedures (see Table 3), that affect the appearance of the facial treatment, at any time during the study period.
- •4. Subject is in institutional care.
- •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 Clinical Research Organisation (CRO) or study sponsor.
- •7. Pregnant or nursing woman or a woman planning a pregnancy during the study.
- •8. Subject 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.
- •9. Subjects who in the opinion of the investigator are unsuitable to take part in the study for scientific or medical reasons.
- •10. Subject suspected to be non-compliant according to the investigator’s judgment.
- •11. Subjects currently enrolled in other clinical trials.
- •12. Subjects with scar(s), mole(s), tattoo(s), semipermanent makeup or facial hair in the region to be treated as this could interfere with study evaluations.
- •13. 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.
- •14. Subject with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.
- •15. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders.
- •16. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta blockers)
- •17. Subject with epilepsy not controlled by treatment.
- •18. Subject with known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement).
- •19. Subject suffering from active disease/symptoms such as inflammation, infection, tumours, psoriasis, allergic oedema, inflammatory and/or infectious cutaneous disorders (e.g., herpes, acne, rosacea) on the face within 6 months of the study entry.
- •20. Subjects with a history of any disease which may have resulted in changes to facial contour or oedema during the study period (e.g., facial psoriasis, herpes zoster).
- •21. Subject with known history of precancerous lesions/skin malignancies.
- •22. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety.
- •23. 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.
- •24. Subject with major dental problems or subject who received oral surgery
研究者
相似试验
进行中（未招募）
不适用
A study to assess the safety and efficacy of hyaluronic acid dermal fillers in the treatment of facial agingISRCTN17960592Sinclair Pharmaceuticals Limited168
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 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 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 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