| CTRI Number |
CTRI/2025/01/078955 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study in participants who requires facial improvement through dermal filler |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BVC-DER-07-0724 Version 1.0 Dated 6 Dec 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debraj Shome |
| Designation |
Consultant |
| Affiliation |
Esthetic Centers International Pvt. Ltd |
| Address |
Esthetic Centers International Pvt. Ltd. 3B & 4, Shradha building no 03, Off 90 feet road
Thakur complex, Kandiwali (East) Mumbai, Maharashtra- 400101.
Esthetic Centers International Pvt. Ltd. 3B & 4, Shradha building no 03, Off 90 feet road
Thakur complex, Kandiwali (East) Mumbai, Maharashtra- 400101.
Mumbai
MAHARASHTRA
400101
India |
| Phone |
07738146661 |
| Fax |
|
| Email |
debraj.shome@ecipl.health |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bhargav Joshi |
| Designation |
AGM CLINICAL AFFAIRS |
| Affiliation |
Biotech vision care pvt ltd |
| Address |
Block 1 Abhishree corporate park, bopal ambli road, south bopal, Ahmedabad
Block 1 Abhishree corporate park, bopal ambli road, south bopal, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
09925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Bhargav Joshi |
| Designation |
AGM CLINICAL AFFAIRS |
| Affiliation |
Biotech vision care pvt ltd |
| Address |
Block 1 Abhishree corporate park, bopal ambli road, south bopal, Ahmedabad
Block 1 Abhishree corporate park, bopal ambli road, south bopal, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
09925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Biotech vision care pvt ltd |
|
|
Primary Sponsor
|
| Name |
Biotech vision care pvt ltd |
| Address |
Block 1 Abhishree corporate park, bopal ambli road, south bopal, Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debraj Shome |
Esthetic Centers International Pvt. Ltd |
Department of clinical research,3rd floor, 3B & 4, Shradha building no 03, Off 90 feet road Thakur complex, Kandiwali (East) Mumbai, Maharashtra- 400101.
Mumbai
MAHARASHTRA |
7738146661
debraj.shome@ecipl.health |
| Dr Kedarnath Pandya |
Mayfair Aesthetic Clinic |
2nd Floor, room number 202 Clinical Research department
Earth Essence, 201-204, Zydus Hospital Rd,
near Baghban party plot, Thaltej,
Ahmedabad, Gujarat 380059
Ahmadabad
GUJARAT |
9825416436
kedarnath6854@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC THE ESTHETIC CLINICS |
Approved |
| Mahavir Hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GLODERM COMFORT 12L |
GLODERM COMFORT 12L is a sterile, transparent, colorless, odorless, pyrogen-free, physiological
solution of cross-linked Hyaluronic Acid which is not of animal origin with Lidocaine.
GLODERM COMFORT 12L (1.0 ml) is Cross-Linked Hyaluronic Acid 1.2% w/v with Lidocaine 0.3% w/v. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
(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 |
|
| ExclusionCriteria |
| Details |
(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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking correction of fine lines on face |
at the time of the
completion of the injection, 15 min, 24 hours, 3-, 7-, 14-, 30- days post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the performance of GLODERM COMFORT 12L Dermal fillers in participants, who are seeking
correction of fine lines on face |
at the time of the
completion of the injection, 15 min, 24 hours, 3-, 7-, 14-, 30- days post treatment |
|
|
Target Sample Size
|
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)
|
01/02/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
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 |