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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2017-09-20

Brief Summary

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

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Detailed Description

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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

Conditions

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Erythema and Flushing Associated With Rosacea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mirvaso® (brimonidine) topical gel, 0.33%

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Dysport®

Intervention Type DRUG

Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

Dysport® in conjunction with Mirvaso

Group Type ACTIVE_COMPARATOR

Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Intervention Type DRUG

Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Interventions

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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.

Intervention Type DRUG

Dysport®

Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

Intervention Type DRUG

Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Intervention Type DRUG

Other Intervention Names

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Dysport® (abobotulinumtoxinA)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes