Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines

Wrinkles Clinical Trial

Official title:

A Prospective, Randomized, Multi-Center, Subject- and Evaluator-Blinded, Parallel Comparison of Dysport®, When Reconstituted at 1.5 mL and 2.5 mL, for the Treatment of Moderate to Severe Glabellar Lines.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718118
• Other study ID #: GLI.04.SPR.US10348
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety, efficacy, and subject and investigator satisfaction of 2 different injection volumes of Dysport in the glabellar lines. 1. To determine the proportion of composite responders (based on blinded evaluator and subject assessments) who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) at maximum frown line on Day 30. 2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits. 3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2 visit (subject and blinded evaluator). 4. To assess the subject's satisfaction with the treatment. 5. To evaluate investigator satisfaction of treatment outcome. 6. To evaluate subject psychological well-being. 7. To evaluate subject age appraisal. 8. To evaluate all adverse events during the course of the study.

Description:

Five month, randomized, subject- and evaluator-blinded, multi-center, mult-visit study. Subjects treated with Dysport following the US on-label guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Key Inclusion Criteria:

1. Botulinum toxin naïve subject (facial area)

2. Moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown and mild to severe (GLSS = 1, 2, or 3) glabellar lines at rest using the validated 4-point Photographic Scale, as assessed by the treating investigator and the blinded evaluator.

Key Exclusion Criteria:

1. Have known allergies or sensitivities to Dysport®, any of its excipients, or cow's milk protein

2. Have rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart

3. Have a history or have signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator

4. Have clinical or subclinical neuromuscular junctional disorders (eg, myasthenia gravis, Lambert Eaton syndrome, or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration

5. Are women who are pregnant or breast-feeding or who intend to get pregnant within the duration of the study

6. Have an active inflammation or infection in the areas to be treated or had any prior surgery, tattoos, piercings, or scarring in the facial area that, in the opinion of the investigator, may interfere with the results

7. Have had any previous insertion of any permanent or semi-permanent material, hyaluronic acid, or collagen fillers in the glabellar region

8. Have any chronic or acute medical condition that, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this study

Related Conditions & MeSH terms

• Glabellar Lines
• Wrinkles

Intervention

Device:
• Dysport reconstituted at 1.5 mL (0.05 mL/injection)
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
• Dysport reconstituted at 2.5 mL (0.08 mL/injection)
Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.

Locations

Country	Name	City	State
United States	Skin Research Institute	Coral Gables	Florida
United States	AboutSkin Dermatology and DermSurgery	Greenwood Village	Colorado
United States	Marina Peredo, MD, PC	Smithtown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.	Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.	30 days
Secondary	Proportion of Responders, at Maximum Frown (Subject)	Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale.	120 days
Secondary	Proportion of Responders, at Maximum Frown (Blinded Evaluator)	Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale.	120 days
Secondary	Proportion of Responders, at Maximum Frown (Treating Investigator)	Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale.	120 days
Secondary	Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)	Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.	120 days
Secondary	Proportion of Responders, at Rest (Subject)	Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale.	120 days
Secondary	Proportion of Responders, at Rest (Blinded Evaluator)	Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale.	120 days
Secondary	Proportion of Responders, at Rest (Treating Investigator)	Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale.	120 days
Secondary	Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)	Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.	120 days
Secondary	Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.	Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7.	7 days
Secondary	Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.	Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120.	120 days
Secondary	Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results	Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30.	30 days
Secondary	Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline	Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100.; Increase in score = increased well-being.	Baseline and Day 120
Secondary	Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline	Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. "0" years represents "current age subjects rated their appearance as older or younger than current age"; "+" years represents "older than current age"; "-" years represents "younger than current age".	Baseline and Day 120
Secondary	Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline	Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines.	Baseline and Day 120