CTRI/2018/06/014685招募中4 期
A prospective, open label, multicentric, single-arm, post marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation.
Biotech Vision Care Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. The patient must be >= 18 and <= 75 years of age.
- •2. The patient must be willing to comply with the requirement of the study, including sequential photography or imaging for which copyright will be held by the Sponsor.
- •3. The patient is willing and able to comply with the study protocol.
- •4. The patient is seeking soft tissue augmentation treatment on the face.
- •5. The patient with folds, lines, wrinkles like Malar area, perioral line, Nasolabial fold, marionette Lines, jaw lines.
- •6. The patient has a pre-treatment Wrinkle Severity Score (WSS) >= 2 for bilateral NLF to be treated
- •7. The patient agrees to follow-up examinations out to 6 months post final treatment and willing to give written informed consent for participation in the study.
排除标准
- •1. At risk in term of precautions, warnings and contra-indication referred in the package insert of the Study devices,
- •2. Who underwent previous injection of permanent filler in the injected area.
- •3. Pregnant/lactating women
- •4. Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic
- •5. Had a chemical peel at the NLF area within 4 weeks prior to Study entry. In addition, subjects were restricted from undergoing chemical peels at the NLF area for the duration of the Study.
- •6. Had any treatment with Botox® injections:
- •a) In the upper 1/3 of the face within 2 weeks prior to entry into the Study, or
- •b) In the lower 2/3 of the face within 24 weeks prior to entry. In addition, subjects were restricted from receiving Botox injections in the face for the duration of the Study.
- •7. Had a history of hypo- or hyperpigmentation of the skin.
- •8. Tolerance to antibiotics or corticosteroids.
- •9. Had any infection, unhealed wound, or active inflammatory process (e.g., skin eruptions such as cysts, pimples, rashes, or hives) at the injection site(s).
- •10. Immunocompromised/immunosuppressed (e.g., HIV-positive, transplant recipient, or presently receiving chemotherapy).
- •11. A known history of keloids or bleeding disorders.
- •12. Leukoderma (vitiligo) or a family history of leukoderma or other pigmentary disorders.
- •13. Patient on Medication with blood thinners.
- •14. Severe physical, neurological or mental disease.
- •15. Excessive facial hair that might interfere with the Study of the wrinkle assessments.
- •16. Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
研究者
相似试验
已完成
2 期
A clinical trial to study the effects of ZYH1 in patients with high triglyceride levels in HIV associated lipodystrophy. .[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS VII)].CTRI/2010/091/000107Cadila Healthcare Limited50
已完成
2 期
A clinical trial to study the effects of 4 mg ZYH1 in patients with Non alcoholic steatohepatitis (NASH)..[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS VIII)].CTRI/2010/091/000108Cadila Healthcare Limited30
已完成
4 期
A Study to Assess safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants with DiabetesCTRI/2020/07/026539Johnson and Johnson Private Limited276
招募中
1 期
A phase I study to evaluate the safety of GBL1204 in patients with neovascular age-related macular degeneratioCTRI/2024/02/063012Gennova Biopharmaceuticals Limited
进行中（未招募）
不适用
An open label, prospective, multicenter, single-arm clinical trial to investigate the safety and the analgesic effectiveness of a low dose (4 mg) OROS hydromorphone hydrochloride as starting dose in opioid-na?ve patients with cancer pain - NDpatients with chronic moderate to severe malignant pain which has not been adequately controlled by previous treatment with NSAIDs, COX-2 inhibitors or paracetamol.MedDRA version: 12.1Level: LLTClassification code 10058019Term: Cancer painEUCTR2009-015931-33-ITJANSSEN-CILAG