Erythema and Flushing Associated With Rosacea
Conditions
Brief summary
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
Detailed 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
Interventions
DRUGDysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
DRUGMirvaso® (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.
DRUGDysport®
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Sponsors
Galderma R&D
Skin Laser & Surgery Specialists
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessments for Erythema | 6 months | % 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. |
| Efficacy Assessments for Flushing | 6 months | % 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments | 6 months | 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. |
Outcome results
None listed