| CTRI Number |
CTRI/2019/09/021257 [Registered on: 16/09/2019] Trial Registered Prospectively |
| Last Modified On: |
16/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal
filler in people with all skin types, who need Lip Enhancement, Cheek bone
Augmentation and Nasolabial fold improvement |
|
Scientific Title of Study
|
A prospective, randomized, comparative, clinical study
to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal
filler 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 |
| CROSSLINKED_HA/11-Jul-19/Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debraj Shome |
| Designation |
Principal Investigator |
| Affiliation |
Esthetic Centers International Pvt Ltd |
| Address |
Esthetic Centers International Pvt Ltd
3B and 4 Shradha building no 03
Off 90 feet road Thakur complex
Kandiwali (East) Mumbai
Mumbai
MAHARASHTRA
400101
India |
| Phone |
|
| Fax |
|
| Email |
debraj.shome@theestheticclinic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debraj Shome |
| Designation |
Principal Investigator |
| Affiliation |
Esthetic Centers International Pvt Ltd |
| Address |
Esthetic Centers International Pvt Ltd
3B and 4 Shradha building no 03
Off 90 feet road Thakur complex
Kandiwali (East) Mumbai
Mumbai
MAHARASHTRA
400101
India |
| Phone |
|
| Fax |
|
| Email |
debraj.shome@theestheticclinic.com |
|
Details of Contact Person
Public Query
|
| Name |
Girish Hirpara |
| Designation |
Sr Manager Clinical Affairs |
| Affiliation |
Biotech Vision Care Pvt Ltd |
| Address |
Block 1 Abhishree Corporate Park
Opp Swagat Bunglow BRTS Stop
Bopal Ambli Road
Ahmedabad
Ahmadabad
GUJARAT
380 058
India |
| Phone |
917966823000 |
| Fax |
|
| Email |
girish.hirpara@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 |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
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 and 4 Shradha building no 03
Off 90 feet road Thakur complex
Kandiwali (East) Mumbai 400101
Mumbai
MAHARASHTRA |
9987398578
debraj.shome@theestheticclinic.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC The Esthetic Clinics |
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 |
Jeunesso 30L cross-linked Sodium Hyaluronate |
Dermal Filler |
| Comparator Agent |
Juvederm Ultra Plus |
Dermal Filler |
| Comparator Agent |
Juvederm Volift |
Dermal Filler |
| Comparator Agent |
Juvederm VolumaTM XC |
Dermal Filler |
|
|
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 needing Cheek bone Augmentation will be enrolled in arm 1 of the
trial.
5. The patient with deep depression of the Nasolabial folds will be enrolled in arm
2 of the trial.
6. The patient needing Lip Enhancement will be enrolled in arm 3 of the trial.
7. The patient agrees to follow-up examinations out to 6 months post final
treatment.
8. 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 fillers,
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:
a) In the upper 1/3 of the face within 2 weeks prior to entry into the study, or
b) 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.
8. Had a history of hypo- or hyperpigmentation of the skin.
9. Tolerance 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
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
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). |
Day 0 to 12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12
Months
To access the frequency and severity of adverse events (AEs) documented at
each study visit |
Day 0 to 3, 6, & 12 months |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/09/2019 |
| 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)
|
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)?
|
|
Brief Summary
|
This is a prospective, randomized, comparative, clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.
Primary objective of this study 1) To Assess and compare the safety and performance of Crosslinked HA (Biotech’s Dermal filler compared to Juvederm Voluma XC for cheekbone Augmentation, Juvederm Ultra Plus XC for nasolabial fold treatment and Juvederm Volift for Lip Enhancement) for subjects with a) Cheek bone Augmentation b) Nasolabial fold improvement c) Lip Enhancement
2) Incidence of all adverse events at 6 and 12 months and any systemic adverse events
and Secondary Objectives of this study 1) Assess dermal filler success in overall face improvement.
2) Evaluate and compare efficacy of Cross-linked HA (Biotech’s dermal filler and Juvederm Voluma XC in Cheek Bone Augmentation, Juvederm Ultra plus XC in treatment of nasolabial folds and Juvederm Volift in Lip Enhancement).
3) Evaluate proportion of population reporting with dermal filler’s adverse effect and during the course of the study.
4) Evaluate and compare long-term safety of Crosslinked HA (Biotech’s Dermal filler and Juvederm Voluma XC, Juvederm Ultra Plus XC and Juvederm Volift) up to 12 Months |