CTRI/2024/12/078208进行中（未招募）Unknown
A Prospective, Single Arm,Clinical Study to assess the safety and performance of GLODERM COMFORT 15L containing Cross-Linked Hyaluronic Acid with Lidocaine, in participants who are seeking correction of fine lines on face.
Biotech Vision Care Pvt. Ltd.3 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年12月27日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Percentage of Improvement on the Investigator’s Global Aesthetic Improvement
研究概览
简要总结
Dermal fillers are a common minimally invasive option for the non-permanent treatment of agerelated facial wrinkles, nasolabial folds, marionette lines, and cheek hollowness. Therefore, it is reasonable to assume that that GLODERM COMFORT 15L will have similar effect in smoothening the wrinkles associated with lines on Philtrum, Border line of lips, Glabella, Marionette, under brows area and under the eye area of face; also, the extent of injection site reactions or adverse reactions as well as the duration of correction will be similar.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Human participants, ≥18 years age. In case of female participant.
- •Non-pregnant, and non-lactating.
- •Able to understand the full nature and the purpose of the investigation, including possible risks and side effects 3.seeking treatment for more than one of the correction sites among six indications for this device – (i) under brows area, (ii) under eye area, (iii) philtrum, (iv) border line of lips, (v) Glabella and (vi) Marionette.
排除标准
- •Have received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs [oral/injectable corticosteroids or Non-Steroidal Anti-inflammatory Drugs (NSAIDs)], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection.
- •Have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrolment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the clinical investigation.
- •Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the clinical investigation or be planning to undergo any of these procedures at any time during the clinical investigation.
- •Have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrolment or be planning to begin use of such products at any time during the clinical investigation.
- •Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads.
- •Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anaesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the clinical investigation.
- •Have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated.
- •Have ongoing neoplastic (including skin cancer) and/or immunosuppressive diseases.
- •Have a known hypocoagulability state; Have medically documented varices in the correction site intended to be treated in this investigation; History of hypertrophic scarring; History of use of narcotic agents, antineoplastics, immunosuppressants or of any other agent that may interfere with healing prior to the screening visit; History of drugs and/or alcohol abuse For female participant who is pregnant, nursing an infant or planning a pregnancy during the clinical investigation [throughout the course of the clinical investigation, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)] Current participation or participation within 30 days prior to the start of this clinical investigation in a drug or other investigational research clinical investigation/ clinical trial.
- •Participants unable to measure pain properly by means of the visual analogue scale (VAS); Have any neurological or psychiatric diseases that may hinder obtaining of informed consent or the adherence to investigation procedures; Planned relocation during the clinical investigation, which would make follow-up visits impossible Participants considered as unsuitable to participate, as per the medical judgement of the Investigator’s opinion Vulnerable population.
结局指标
主要结局
Percentage of Improvement on the Investigator’s Global Aesthetic Improvement
时间窗: Time Frame: 30 days post treatment
Scale (I-GAIS)
时间窗: Time Frame: 30 days post treatment
次要结局
- 1. Percentage of Improvement on the Investigator’s Global Aesthetic - 90 days & 180 days post treatment.(2. Percentage of Improvement on the Patients Global Aesthetic -30 days, 90 days & 180 days post treatment.)
研究者
Dr Sonal Shendkar
Skinovate Laser and Cosmetic Surgery Center
研究点 (3)
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