| CTRI Number |
CTRI/2018/11/016357 [Registered on: 15/11/2018] Trial Registered Prospectively |
| Last Modified On: |
12/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Phase IV |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective Phase IV study at different centers without any competitor,Single dose clinical study to assess the safety and efficacy of glabellar lines DYSPORT® in adult subjects for treatment of glabellar lines moderate-to-severe the area on frontal bone above the nose and between the eyebrows |
|
Scientific Title of Study
|
A prospective, Phase IV, multi-center, open label, Single dose clinical study to demonstrate the safety and efficacy of DYSPORT® in adult subjects for treatment of moderate-to-severe glabellar lines |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/NSH/DYS/01/2017 ,V:02 Date:04/07/ 2018 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
G-13, Newbridge Business Center, Innox Tower, Sec 16A, Noida, UP- 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
G-13, Newbridge Business Center, Innox Tower, Sec 16A, Noida, UP- 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
G-13, Newbridge Business Center, Innox Tower, Sec 16A, Noida, UP- 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Cliniexperts Services Private Limited, Janakpuri ,New Delhi |
|
|
Primary Sponsor
|
| Name |
Cliniexperts Services Private Limited |
| Address |
Jankpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Batra |
Dermaworld Skin and hair clinic |
Q-4 ground floor first room, Rajauri Garden, Near janta market , New Delhi-110060
New Delhi
DELHI |
9911100050
drrohitbatra@gmail.com |
| Dr Rashmi Sarkar |
MAMC New delhi |
Ward no 22, first floor , dermatology Department , Maulana Azad Medical College, New Delhi
New Delhi
DELHI |
9968604370
rashmisarkar@gmail.com |
| Dr Sanjay Kumar Mittal |
Mittal Allergy Clinic |
Ground floor OPD No-2, Vidhya Nagar Jaipur
Jaipur
RAJASTHAN |
9785245155
drsanjay25@yahoo.com |
| Dr Savitha S |
Rajlakshmi Hospital |
No 22/1, Lakshmipura main Road, Opp Lakshmipura Lake, Vidyanarayan post, Banglooore 560097
Bangalore
KARNATAKA |
9880512166
drsavithasomaiah@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
| Rajlakshmi Hospital Institutional Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Subjects is Male or Female, 18 to 65 years of age
2. Subject has grade 2-3 moderate to severe glabellar lines at maximum frown as assessed by the investigator using 4-point photographic glabellar line severity scale (GLSS)
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects is an adult, of at least 18-65 years of age
2. Subject has grade 2-3 moderate to severe glabellar lines at maximum frown as assessed by the investigator using 4-point photographic glabellar line severity scale (GLSS)
3. Subject is willing and able to complete the entire course of the study as per the study protocol.
4. Subject is able to provide informed consent and comply with study instructions
|
|
| ExclusionCriteria |
| Details |
1. Previous treatment with botulinum toxin of any serotype in any area within the last 6 months.
2. Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
3. Previous insertion of permanent material in the glabellar area
4. Planned treatment with botulinum toxin of any serotype in any other body region during the study period
5. Any surgery in the glabellar area including surgical removal of the corrugators, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
6. Energy-based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
7. Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
8. Marked facial asymmetry
9. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
10. History of facial nerve palsy
11. Subjects with previous or current diagnosis of Bell’s paresis.
12. Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
13. Subjects who are taking anticholinergics or aminoglycoside antibiotics.
14. Subjects with active inflammation or infection in the areas to be treated.
15. Subjects with history of any other adverse effect, which should prevent the subject from participating in the study according to the investigator’s opinion.
16. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.
17. 14. Other condition preventing the subject from entering the study in the investigator’s opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
18. Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
19. Any active infection in the area of the injection sites
20. Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
21. Evidence of recent alcohol or drug abuse
22. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
23. Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception in next 12 months.
24. Known allergy or hypersensitivity to botulinum toxin preparation
25. Participation in another interventional clinical study within the last 30 days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of DYSPORT® in subjects for treatment of moderate-to-severe glabellar lines on the basis of treatment-emergent adverse event monitoring throughout study period i. e from baseline(day 1) to day 180(+ 2 Days) |
Day 1, 30, 90,180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of DYSPORT® in subjects for treatment of moderate-to-severe GLSS 4-point photographic GLSS at maximum frown at baseline(Day 1), day30, day90 and day180
To assess patient satisfaction after single injection of Dysport® after treatment using patient satisfaction questionnaire at Day30,Day90 and Day180
To assess physician satisfaction after one injection of Dysport® using physician satisfaction questionnaire at Day 30 and day 90 and Day,180
|
Day 1, 30, 90,180 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2018 |
| Date of Study Completion (India) |
05/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a phase IV clinical study which involves the collection of clinical data to evaluate the safety and effectiveness of Dysport® in subjects undergoing treatment of Moderate-to-severe Glabellar Lines. Glabellar lines are the short vertical lines found between the eyebrows and extending up the central forehead for a centimeter or so. They are often the first wrinkles to appear on the forehead even as early as the mid 20’s or more when person gets older. They make the person look older and slightly angry. With increasing clinical usage of cosmetic treatment through botox agents in treatment of Moderate-to-severe Glabellar Lines., regulatory agencies expect the continued submission of clinical phase IV data on the treatment used for Moderate-to-severe Glabellar Lines. Therefore, regulatory agencies are interested in evaluating the clinical phase IV data of these botox agents for its safety and efficacy.
Hence this clinical phase IV studies will be done just to verify the safety and effectiveness of a marketed drug of Nestle Skin Health India Pvt. Ltd i:e; Dysport® in subjects undergoing treatment of Moderate-to-severe Glabellar Lines.
|