Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea

Erythema and Flushing Associated With Rosacea Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03508869
• Other study ID #: MG-DYS-ROS
• Status: Terminated
• Phase: N/A
• Start date: September 27, 2016
• Est. completion date: September 20, 2017

Study information

• Verified date: April 2023
• Source: Skin Laser & Surgery Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.

Description:

To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female

2. 18 years of age or older

3. Clinical diagnosis of rosacea

4. Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)

5. No known medical conditions that may interfere with study participation

6. Willingness to not use any products on their face for the duration of the study

7. Read, understand, and sign informed consent forms

8. Willingness to sign photography release form

9. Willing and able to comply with all follow-up requirements

10. Willingness to undergo treatment using Mirvaso® Gel and Dysport®

Exclusion Criteria:

1. Any significant skin disease at treatment area

2. Any medical condition which could interfere with the treatment

3. Inability or unwillingness to follow the treatment schedule

4. Inability or unwillingness to sign the informed consent

5. Pregnant or lactating

6. Allergy to cow's milk protein

7. Previous or current use of Mirvaso® Gel

8. Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients

9. Previous Dysport® treatment 6 months prior to the screening visit

Related Conditions & MeSH terms

• Erythema
• Erythema and Flushing Associated With Rosacea
• Flushing
• Rosacea

Intervention

Drug:
• Mirvaso® (brimonidine) topical gel, 0.33%
Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.
• Dysport®
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
• Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Skin Laser & Surgery Specialists	Galderma R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessments for Erythema	% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or = 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale.	6 months
Primary	Efficacy Assessments for Flushing	% of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or = 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale.	6 months
Secondary	Safety Assessments	Safety evaluations will be performed at all visits. Adverse events, local tolerability (dryness, pruritus burning/stinging) and a facial exam will be performed for all visits.	6 months