An interventional study of Mirvaso® (brimonidine) topical gel, 0.33% and Dysport® in Erythema and Flushing Associated With Rosacea, sponsored by Skin Laser & Surgery Specialists. Terminated. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Skin Laser & Surgery Specialists · Not applicable, Interventional, and Treatment
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
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
Exclusion Criteria:
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.
Drug: Mirvaso® (brimonidine) topical gel, 0.33%
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Drug: Dysport®
Dysport® in conjunction with Mirvaso
Drug: Dysport® in conjunction with 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® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Also known as: Dysport® (abobotulinumtoxinA)
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
No study locations are listed for this record.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Skin Laser & Surgery Specialists