| CTRI Number |
CTRI/2024/12/078208 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BVC-DER-11-1024 Version No.: 02 Date: 09 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Shendkar |
| Designation |
Consultant |
| Affiliation |
Skinovate Laser and Cosmetic Surgery Center |
| Address |
Taluka-Haveli, Office No. 302 and 303, Third Floor, Royal Avenue, Survey No. 18 Hissa No. 11/6, Next to Hotel Shivar Garden, Pimple Saudagar, Rahatan
Pune
MAHARASHTRA
411017
India |
| Phone |
|
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhargav Joshi |
| Designation |
AGM Clinical Affairs |
| Affiliation |
Biotech Vision Care Pvt Ltd |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop, Bopal - Ambli Road, Ahamdabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
9925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhargav Joshi |
| Designation |
AGM Clinical Affairs |
| Affiliation |
Biotech Vision Care Pvt Ltd |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop, Bopal - Ambli Road, Ahemdabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Biotech Vision Care Pvt. Ltd.
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow,
BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Biotech Vision Care Pvt. Ltd. |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road,
Ahmedabad - 380 058
Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Salil Patil |
Absolute Clinic |
Wipro Circle, Geras Imperium Rise, Hinjewadi, Phase-2, Pune-411057
Pune
MAHARASHTRA |
8980208978
patilsalil23@gmail.com |
| Dr Sonal Shendkar |
Skinovate Laser & Cosmetic Surgery Centre |
Taluka-Haveli, Office No. 302 and 303, Third Floor, Royal Avenue, Survey No. 18 Hissa No. 11/6, Next to Hotel Shivar Garden, Pimple Saudagar, Rahatani, Pune-411017
Pune
MAHARASHTRA |
9960178611
drsonal.skinovate@gmail.com |
| Dr Sonam Ramrakhiani |
Srishti Skin Clinic |
Hill Spring, office No-09, 1st floor, Vijay Garden Road Room no 09
Floor 1st Floor
Department:DermatologyThane(west)-400615
Thane
MAHARASHTRA |
9987756530
jeswanisonam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Human participants, ≥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 – (i) under brows area, (ii) under eye area, (iii)
philtrum, (iv) border line of lips, (v) Glabella and (vi) Marionette.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of Improvement on the Investigator’s Global Aesthetic Improvement
Scale (I-GAIS) |
Time Frame: 30 days post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
Improvement Scale (I-GAIS) |
Time Frame: as mentioned above |
|
Target Sample Size
Modification(s)
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |