| CTRI Number |
CTRI/2017/09/009848 [Registered on: 19/09/2017] Trial Registered Prospectively |
| Last Modified On: |
12/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Restylane® used for treatment of facial wrinkles, facial folds, volume loss and lips augmentation. |
|
Scientific Title of Study
|
An Prospective,open label,multicentric, single-arm, non-comparative post marketing clinical study to evaluate effectiveness and safety of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/GAL/RES/01/2017, Version No: 01, Date-10 July 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Batra |
| Designation |
Sr Consultant, Dermatology |
| Affiliation |
Derma World Skin and Hair Clinic |
| Address |
Department of Dermatology,
Room No. 1
Derma World Skin and Hair Clinic
Q-4, Rajouri Garden, Near Janta Market, New Delhi
West
DELHI
110027
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
dr.rohitbatra73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director clinical operations |
| Affiliation |
Cliniexperts |
| Address |
Room No.3
Unit No. 510,112,113,114
C-58, Shahpuri Tower, Janakpuri, New Delhi
West
DELHI
1100058
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
dr.kumardevesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director clinical operations |
| Affiliation |
Cliniexperts |
| Address |
Room No. 3
Unit No. 510,112,113,114
C-58, Shahpuri Tower, Janakpuri, New Delhi
West
DELHI
1100058
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
dr.kumardevesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galderma India Pvt Ltd
Address: Lotus Corporate Park, D Wing Unit 801802 Off Western Express Highway, Goregaon (East), Mumbai, Maharashtra 400063 |
|
|
Primary Sponsor
|
| Name |
Galderma India Pvt Ltd |
| Address |
Lotus Corporate Park, D Wing Unit 801802 Off Western Express Highway, Goregaon (East), Mumbai, Maharashtra 400063 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Agarwal |
Avante Skin and Cosmetic Surgery Clinic |
Department of Dermatology,
Room No.1
E-342,M Block, Greater Kailash 2, New Delhi, Delhi 110048
South
DELHI |
9971104763
priyankaag14087@gmail.com |
| Dr Rohit Batra |
Derma World Skin and Hair Clinic |
Department of Dermatology,
Room No.1
Q-4, Rajouri Garden, Near Janta Market, New Delhi-110027
West
DELHI |
9911100050
dr.rohitbatra73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Facial Wrinkles, Lip Augmentation, Facial Folds and Volume Loss., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Restylane Lidocaine and Restylane Perlane Lidocaine |
Composition-
Hyaluronic acid stabilized- 20 mg/ml
Lidocaine hydrochloride - 3 mg/ml
Phosphate buffered saline - q.s |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female of age between 18 to 55 years
2. Subjects intending to undergo facial filler treatment for either volume loss or contouring in midface as per investigator’s judgment/opinion
3. Subjects requiring treatment for lip augmentation or rejuvenation.
4. Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period
5. Female subjects of childbearing potential who agree to use medically acceptable contraception (e.g., condom, oral contraceptives continuing from at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial
6. Non-pregnant, non-breast feeding females
7. Subjects who voluntarily decided to participate in the study and willing to give the informed consent
8. Able to understand and follow instructions and participate the entire period of the clinical trial.
|
|
| ExclusionCriteria |
| Details |
1. Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents;
2. Subjects with traumatic scars or ongoing active skin disease in the area to be treated
3. Permanent implant or filler, including fat injection placed in the area to be treated
4. Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
5. Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steroidal anti-inflammatory drugs, acetylsalicylic acid, omega 3 and Vitamin E) within 2 weeks prior to treatment
6. Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (Inhaled corticosteroids are allowed)
7. Active or chronic skin disease, inflammation or related conditions (skin eruptions such as cysts, pimples, rashes, or hives), near or on the Nasolabial Folds
8. Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
9. History of chronic sinusitis or rhinitis (only applicable for subjects injected over the nose).
10. Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skin boosters in the facial area within 12 months before treatment.
11. Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
12. Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
13. Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
14. Patients with bleeding disorders
15. Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss |
Visit I (Day 0), Visit II (Day 14), Visit III (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Restylane® Lidocaine in subjects undergoing treatment for facial wrinkles and lip augmentation and Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds and volume loss |
Visit I (Day 0), Visit II (Day 14), Visit III (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/09/2017 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An
Prospective,open label,multicentric, single-arm, non-comparative post marketing
clinical study to evaluate effectiveness and safety of Restylane® Lidocaine in
subjects undergoing treatment for facial wrinkles and lip augmentation and
Restylane® Perlane Lidocaine in subjects undergoing treatment for facial folds
and volume loss. Total 100 subjects would be enrolled in the study and study consists of 3 visits at Day-0 , Day- 14 and Day- 30. The efficacy assessment will be done through- Wrinkle Severity Rating Scale (WSRS), Global
Aesthetic Improvement Scale (GAIS), Lip Fullness Grading Scale (LFGS), Medicis Midface Volume Scale.
|