Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: GLODERM COMFORT 15L [1 ml]
: [Dermal filler containing Cross-Linked Hyaluronic
Acid 1.5%w/v with Lidocaine 0.3%w/v] One time administration of the injection
Control Intervention1: No
Sponsors
Biotech Vision Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Human participants, â?¥18 years age. In case of female participant - Non-pregnant, and non-lactating. 2. 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 â?? (i) under brows area, (ii) under eye area, (iii) philtrum, (iv) border line of lips, (v) Glabella and (vi) Marionette.
Exclusion criteria
Exclusion criteria: 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 Investigatorâ??s opinion Vulnerable population
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Improvement on the Investigatorâ??s Global Aesthetic Improvement Scale (I-GAIS)Timepoint: Time Frame: 30 days post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Improvement on the Investigatorâ??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. Improvement Scale (I-GAIS)Timepoint: Time Frame: as mentioned above | — |
Countries
India
Contacts
Public ContactBhargav Joshi
Biotech Vision Care Pvt Ltd
Outcome results
None listed