| CTRI Number |
CTRI/2010/091/006096 [Registered on: 18/01/2011] |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
|
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Drug
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Comparative study on the safety and efficacy of Hyfil and Restylane for correction of nasolabial folds |
Scientific Title of Study
Modification(s)
|
Comparative study on the safety and efficacy of Hyfil and Restylane for correction of nasolabial folds |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| VB102/2010-CT2 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mukta Sachdev |
| Designation |
|
| Affiliation |
|
| Address |
MS Clinical Research Pvt
Bangalore
Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukta.sachdev@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr TC Raghuram |
| Designation |
Medical Director |
| Affiliation |
Medical Director |
| Address |
Virchow Biotech Pvt Ltd
Hyderabad
Hyderabad
ANDHRA PRADESH
500 018
India |
| Phone |
04023800924 |
| Fax |
04023800925 |
| Email |
tcraghuram@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr TC Raghuram |
| Designation |
Medical Director |
| Affiliation |
Medical Director |
| Address |
Virchow Biotech Pvt Ltd
Hyderabad
Hyderabad
ANDHRA PRADESH
500 018
India |
| Phone |
04023800924 |
| Fax |
04023800925 |
| Email |
tcraghuram@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Virchow Biotech Pvt Ltd Flat No.: 101 & 102, Rams Enclave Erragadda, Hyderabad - 500 016, India Phone No.: 91-40-23800924 |
|
Primary Sponsor
Modification(s)
|
| Name |
Virchow Biotech Pvt Ltd |
| Address |
Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMukta Sachdev |
MS Clinical Research Pvt. Ltd |
Mezzanine Floor, Classic Court , 9/1 Richmond Road,-560025
Bangalore
KARNATAKA |
08040917253
08041125934
mukta.sachdev@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clincom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, Nasolabial fold correction , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Hyfil Regular |
1 ml |
| Comparator Agent |
Restylane |
1 ml |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1. Subjects of both genders completed 18 years of age;
2. Subjects with moderate to severe bilateral nasolabial folds with wrinkle severity rating scale scores of 3 or 4;
3. Subjects willing to abstain from other cosmetic procedures (further augmentation therapy, laser or chemical skin resurfacing, botulinun toxin injections, or facelift procedures) during the study period;
4. Subjects who are willing to sign the informed consent and will be available for all follow-up visits.
5. Not on any painkillers/anti-inflammatory/antioxidant drugs, aspirin and other anticoagulant drugs 10 days prior to the screening;
6.No history of keloid tendency;
7.In case of female volunteers, negative pregnancy test during screening.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women;
2.Subjects who had previously received facial soft tissue augmentation with hyaluronic acid or other types of fillers, or cosmetic facial surgery/implants, botulinum toxin injections, or face lift procedures within the previous 6 months from screening date.
3.Subjects who had received laser treatment and chemical peeling in the past 3 months from screening date;
4.Subjects with history of allergic reaction to the study product.
5.Any medical history of systemic diseases (liver or renal functional abnormalities, uncontrolled metabolic diseases, neurological diseases) or serious medical illness;
6.Alcohol or drug or medication abuse;
7.Protocol non-compliant subjects;
8.Any significant laboratory findings
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in wrinkle severity rating scale (WSRS) from baseline to 2, 8, 16, 24 weeks during post therapy ? assessment by investigator. |
weeks 2, 8, 16 and 24 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in global aesthetic improvement scale (GAIS) from baseline to 2, 8, 16, 24 weeks during post therapy - assessment by both investigator and patient; |
weeks 2, 8, 16 and 24 |
| Incidence of adverse events and local injection site reactions |
Week 2, 8, 16 and 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
17/01/2011 |
| Date of Study Completion (India) |
05/06/2012 |
| Date of First Enrollment (Global) |
17/01/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a Phase IV, double blind, randomized, prospective, split-face, comparative clinical study to compare the safety and efficacy of Hyfil Regular and Restylane in reducing nasolabial folds. Both male and female healthy volunteers, who completed 18 years of age and fulfill the inclusion and exclusion criteria, are taken into the study. Initial Wrinkle Severity Rating Scale (WSRS) is done separately each nasolabial folds to include only the subjects with moderate to severe folds. Laboratory investigations ? 6 ml of blood is drawn for laboratory investigations, that is, haematology (CBP, platelet count, and haemoglobin), biochemistry (alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase; serum creatinine, blood urea nitrogen and random blood sugar). Urine pregnancy test is done for women of reproductive age group on baseline visit. All the laboratory reports are received & documented in order to satisfy IC/EC criteria. Those subjects with clinically insignificant laboratory findings and negative urine pregnancy test (in case of females in reproductive age group) and who are eligible will be enrolled on intervention day (Visit 2). All the subjects were followed up on week 2, 8, 16 and 24. All the investigations carried out at baseline and at the end of study period of 6 months. All the laboratory reports are documented. |