| CTRI Number |
CTRI/2021/12/039025 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
25/12/2021 |
| 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 enhancement through dermal filler (JEUNESSO 30L). |
|
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 30L) 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 Debraj Shome |
| Designation |
Plastic Surgeon |
| 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
Same as Address 1
Mumbai (Suburban)
MAHARASHTRA
400101
India |
| Phone |
7400250158 |
| Fax |
|
| Email |
debraj.shome@theestheticclinic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debraj Shome |
| Designation |
Plastic Surgeon |
| 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
Same as Address 1
Mumbai (Suburban)
MAHARASHTRA
400101
India |
| Phone |
7400250158 |
| Fax |
|
| Email |
debraj.shome@theestheticclinic.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debraj Shome |
| Designation |
Plastic Surgeon |
| 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
Same as Address 1
Mumbai (Suburban)
MAHARASHTRA
400101
India |
| Phone |
7400250158 |
| Fax |
|
| Email |
debraj.shome@theestheticclinic.com |
|
|
Source of Monetary or Material Support
|
| Esthetic Centers International Pvt. Ltd.
3B & 4, Shradha building no 03,
Off 90 feet road Thakur complex,
Kandiwali (East) Mumbai,
Maharashtra- 400101 |
|
|
Primary Sponsor
|
| Name |
Dr Debraj Shome |
| Address |
Esthetic Centers International Pvt. Ltd.
3B & 4, Shradha building no 03,
Off 90 feet road Thakur complex,
Kandiwali (East) Mumbai,
Maharashtra- 400101 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debraj Shome |
Esthetic Centers International Pvt. Ltd |
3B & 4, Shradha building no 03,
Off 90 feet road Thakur complex,
Kandiwali (East) Mumbai,
Maharashtra- 400101
Mumbai (Suburban)
MAHARASHTRA |
7400250158
debraj.shome@theestheticclinic.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC THE ESTHETIC CLINICS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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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 |
JEUNESSO 30L (0.5 ml / 0.8 ml / 1.0 ml) Cross-Linked Sodium Hyaluronate Solution 3% W/V
Composition: Each ml contains:
Cross-Linked Sodium Hyaluronate……..30mg |
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 30L 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 30L adds volume to the Skin, smoothing unwanted lines and wrinkles.JEUNESSO 30L consists of cross-linked or non-crosslinked Hyaluronic Acid formulated to a concentration of 30 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 Score (WSS) ≥ 2 for bilateral NLF to be treated |
|
| ExclusionCriteria |
| Details |
1. At risk in term of precautions, warnings and contra-indication 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 NLF area within 4 weeks prior to study entry. In addition, subjects were restricted from undergoing chemical peels at the NLF area for the duration of the study.
7. Had any treatment with Botox® injections:
8. In the upper 1/3 of the face within 2 weeks prior to entry into the study, or
9. In the lower 2/3 of the face within 24 weeks prior to entry. In addition, subjects were restricted from receiving Botox injections in the face for the duration of the study.
10. Had a history of hypo- or hyperpigmentation of the skin.
11. Tolerance to antibiotics or corticosteroids.
12. 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).
13. A known history of keloids or bleeding disorders.
14. Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary disorders.
15. Patient on Medication with blood thinners.
16. Severe physical, neurological or mental disease.
17. Excessive facial hair that might interfere with the study of the wrinkle assessments |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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).
Time points:(Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up) |
Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.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
2. To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 Months
3. 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/12/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 a prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler (JEUNESSO 30L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement. Investigational product to be used is Juenesso 30L is a transparent gel made up of novel cross-linked hyaluronic acid with concentration of 30 mg/ml which is already approved in INDIA. 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 and during the course of the study. 4. Evaluate long-term safety up to 12 Months
Following endpoints will measured during the trial:
Primary Endpoint:
1. 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)
Secondary Endpoint: 1.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 2. To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 Months 3.To access the frequency and severity of adverse events (AEs) documented at each study visit.
|