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

• Status: Terminated
• Trial end date: 2017-09-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Skin Laser & Surgery Specialists
• Collaborators: Galderma; Galderma R&D
• Treatments: abobotulinumtoxinA; Acetylcholine Release Inhibitors; Adrenergic Agonists; Adrenergic alpha-Agonists; Botulinum Toxins, Type A; Brimonidine Tartrate; Neuromuscular Blocking Agents; onabotulinumtoxinA

Criteria

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