| CTRI Number |
CTRI/2023/03/050208 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study in people who require facial improvement through dermal filler (JEUNESSO
20L) |
|
Scientific Title of Study
|
A prospective, single arm, investigator initiated clinical study to assess
the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler
(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement,
Cheek bone Augmentation and Nasolabial fold improvement.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Talanikar |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college |
| Address |
Dr.D.Y.Patil medical college and research centre, sant tukaram nagar, pimpri pune-411018
india
Pune
MAHARASHTRA
411018
India |
| Phone |
9422087726 |
| Fax |
|
| Email |
hemant.vasant16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Talanikar |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college |
| Address |
Dr.D.Y.Patil medical college and research centre, sant tukaram nagar, pimpri pune-411018
india
Pune
MAHARASHTRA
411018
India |
| Phone |
9422087726 |
| Fax |
|
| Email |
hemant.vasant16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Talanikar |
| Designation |
professor |
| Affiliation |
Dr.D.Y.Patil medical college |
| Address |
Dr.D.Y.Patil medical college and research centre, sant tukaram nagar, pimpri pune-411018
india
Pune
MAHARASHTRA
411018
India |
| Phone |
9422087726 |
| Fax |
|
| Email |
hemant.vasant16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil medical college and research centre, pune |
|
|
Primary Sponsor
|
| Name |
Dr. Hemant Talanikar |
| Address |
Dr. D.Y.Patil medical college and research centre, pune |
| Type of Sponsor |
Other [self] |
|
|
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 Hemant Talanikar |
Dr. DY Patil medical college and research centre |
Dr. DY Patil medical college and research centre, sant tukaram nagar, pimpri Pune 411018
Pune
MAHARASHTRA |
9422087726
hemant.vasant16@gmail.com |
| Dr Vivek Mehta |
Dr. Poppy Dental & Facial Aesthetic Clinic |
Research dept, Ground Floor 2, Shakti palace, prem chand nagar rd society,opp. konark karishma,Vastrapur.
Ahmadabad
GUJARAT |
7069448881
drpoppydentalclinic@gmail.com |
| Dr Kedarnath Pandya |
May fair Aesthetic Surgery |
202, 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= 3 |
| Name of Committee |
Approval Status |
| Ethics committee-Dr..D.YPatil vidyapeeth |
Approved |
| Institutional ethics committee aatman hospital |
Approved |
| Institutional ethics committee aatman hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jeunesso 20L (0.5 ml / 0.8 ml / 1.0 ml)
Cross-Linked Sodium Hyaluronate
Solution 2% W/V
Each ml contains:
Cross-Linked
Sodium Hyaluronate……..20mg
Phosphate Buffer
Saline...........................q.s. |
Dose: Not applicable as this will
depend upon type of patient
Frequency: Depends upon
requirement during surgery
Route of administration:
Intradermal Treatment Duration:
day 1 on which treatment is
done JEUNESSO 20L is dermal
filler made from a highly purified
form of Hyaluronic Acid from
non-animal origin that mimics
the effects of natural Hyaluronic
Acid. When injected just below
the surface of the Skin,
JEUNESSO 20L adds volume
to the Skin, JEUNESSO 20L
formulated to a concentration of
20 mg/ml suspended in a
physiological buffer. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient must be ≥ 18 and ≤ 75 years of age.
2. The patient is willing and able to comply with the study
protocol.
3. The patient is seeking soft tissue augmentation treatment
on the face.
4. The patient agrees to follow-up examinations out to 12
months post final treatment.
5. The patient has a pre-treatment Wrinkle Severity Rating
Scale (WSRS) ≥ 2 for bilateral Nasolabial Fold (NLF) to
be treated
|
|
| ExclusionCriteria |
| Details |
1. At risk in term of precautions, warnings and contraindication referred in the package insert of the study
dermal filler
2. Who underwent previous injection of permanent filler in
the injected area
3. Pregnant/lactating women
4. Participation in any other Clinical trial.
5. Subjects who have an allergy to lidocaine, prilocaine or
other amide-type anesthetic
6. Had a chemical peel at the Nasolabial Fold (NLF) area
within 4 weeks prior to study entry. In addition, subjects
were restricted from undergoing chemical peels at the
Nasolabial Fold (NLF) area for the duration of the study
8. Had a history of hypo- or hyperpigmentation of the skin.
9. Inolerance to antibiotics or corticosteroids.
10. Had any infection, unhealed wound, or active
inflammatory process (e.g., skin eruptions such as cysts,
pimples, rashes, or hives) at the injection site(s).
11. A known history of keloids or bleeding disorders.
12. Leukoderma (Vitiligo) or a family history of leukoderma
or other pigmentary disorders.
13. Patient on Medication with blood thinners.
14. Severe physical, neurological or mental disease.
15. Excessive facial hair that might interfere with the study
of the wrinkle assessments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(Pre-operative, Day-0, 3 Month, 6 Month and
12 Months Post-Operative Follow-up)
A. The primary efficacy endpoint is responder rate in GAIS
Score from Day 0 to 12 Months and study of the safety
and severity of adverse events (AEs) |
(Pre-operative, Day-0, 3 Month, 6 Month and
12 Months Post-Operative Follow-up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. To evaluate the Cheek bone Augmentation, the
improvement in the Nasolabial fold and Evaluate Lip
Enhancement from Day 0 to 3, 6 and 12 Months
B. To access Global Aesthetic Improvement Scale from Day
0 to 3, 6 and 12 Months
C. To access the frequency and severity of adverse events
(AEs) documented at each study visit |
(Pre-operative, Day-0, 3 Month, 6 Month &
12 Months Post-Operative Follow-up):
|
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this is prospective, single arm, investigator initiated clinical study to assess
the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler
(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement,
Cheek bone Augmentation and Nasolabial fold improvement.
Primary Objective:
1) To Assess the safety and performance of Crosslinked HA
for cheekbone Augmentation, nasolabial fold treatment and
Lip Enhancement
2) Incidence of all adverse events at 6 and 12 months and any
systemic adverse events. Secondary Objective:
1) Assess dermal filler success in overall face improvement.
2) Evaluate efficacy of Cross-linked HA in Cheek Bone
Augmentation, nasolabial folds and Lip Enhancement
3) Evaluate proportion of population reporting with dermal
filler’s adverse effect during the course of the study.
4) Evaluate long-term safety up to 12 Months. |