CTRI/2025/01/078955
Recruiting
Post Marketing Surveillance
A Prospective, Single Arm Clinical Study to assess the Safety and Performance of GLODERM COMFORT 12L containing Cross-Linked Hyaluronic Acid 12 mg with Lidocaine 3 mg in participants who are seeking correction of fine lines on the face
Biotech vision care pvt ltd2 sites in 1 country85 target enrollmentStarted: February 1, 2025Last updated:
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Biotech vision care pvt ltd
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- To assess the safety of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking correction of fine lines on face
Overview
Brief Summary
Purpose of trial:
The purpose of this clinical study is to assess the safety and performance of GLODERM COMFORT 12L in participants, seeking correction of fine lines including cheek, Smoker lines, Crow’s feet, and Superficial frontal wrinkles.
Objective:
To assess the safety of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking correction of fine lines on face
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •(1) Male or female, Age 18 years or above (2) seeking treatment for more than one of the correction sites among four indications for this device (i) Fine lines of Cheek, (ii) Smoker Lines, (iii) Crow feet lines (iv) Superficial frontal (3) able to understand the full nature and the purpose of the clinical study including possible risks and side effects able to cooperate with the Investigator and to comply with the requirements of the entire study ability to attend all the planned study site visits according to the time limits included and abstaining from exclusionary procedures for the duration of the clinical study based on this study protocol (4) Given consent to allow the use device related data for scientific purposes.
- •(5) Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- •(6) Willingness and ability to comply with protocol requirements including returning for follow up visits and abstaining from exclusionary procedures for the duration of the study.
- •(7) In case of female participant Nonpregnant and nonlactating and willing to use any of the effective contraceptive methods listed by Investigator.
Exclusion Criteria
- •(1) Received anti coagulation anti platelet or thrombolytic medications anti-inflammatory drugs (2) 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 study (3) is suffering from untreated epilepsy.
- •(4) has known hypersensitivity to hyaluronic acid or to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria (5) has known hypersensitivity to lidocaine or to amide type local anaesthetics (6) is suffering from porphyria has undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months (7) has begun use of any new overthecounter 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 study.
- •(8) Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids or large infraorbital fat pads, based on Investigator medical discretion (9) Have a history of anaphylaxis, multiple severe allergies atopy or allergy to lidocaine hyaluronic acid products or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study (10) Have noticeable acne scarring, an active inflammation lesion or unhealed wound or have undergone radiation treatment in the area to be treated (11)has cutaneous inflammatory and infectious processes like acne (12) tends to develop hypertrophic scarring (13) has ongoing neoplastic including skin cancer or immunosuppressive diseases (14) has a known hypocoagulability state (15) has medically documented varices in the correction site intended to be treated in this study (16) has history of hypertrophic scarring (17) has history of use of narcotic agents antineoplastics immunosuppressants or of any other agent that may interfere with healing prior to the screening visit (18) has history of drugs and/or alcohol abuse (19) is simultaneously undergoing laser treatment deep chemical peels or treatments like dermabrasion.
- •(20) is current participating or has participated within 30 days prior to the start of this clinical study.
Outcomes
Primary Outcomes
To assess the safety of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking correction of fine lines on face
Time Frame: at the time of the | completion of the injection, 15 min, 24 hours, 3-, 7-, 14-, 30- days post treatment
Secondary Outcomes
- To assess the performance of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking(correction of fine lines on face)
Investigators
Dr Debraj Shome
Esthetic Centers International Pvt. Ltd
Study Sites (2)
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