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

Phase 4

Completed

• Conditions: 1.Subjects is Male or Female, 18 to 65 years of age2.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)

• Registration Number: CTRI/2018/11/016357
• Lead Sponsor: Cliniexperts Services Private Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study Completion: 2019-05-12
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subjects who are taking anticholinergics or aminoglycoside antibiotics.
• 14.Subjects with active inflammation or infection in the areas to be treated.
• Subjects with history of any other adverse effect, which should prevent the subject from participating in the study according to the investigator’s opinion.
• 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.
• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Dermaworld Skin and hair clinic; 🇮🇳 Delhi, DELHI, India

MAMC New delhi; 🇮🇳 Delhi, DELHI, India

Mittal Allergy Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Rajlakshmi Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dermaworld Skin and hair clinic

🇮🇳Delhi, DELHI, India

Dr Rohit Batra

Principal investigator

9911100050

drrohitbatra@gmail.com