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

Primary Purpose

Erythema and Flushing Associated With Rosacea

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirvaso® (brimonidine) topical gel, 0.33%
Dysport®
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Sponsored by
Skin Laser & Surgery Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythema and Flushing Associated With Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Mirvaso® (brimonidine) topical gel, 0.33%

    Dysport®

    Dysport® in conjunction with Mirvaso

    Arm Description

    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.

    Dysport® in conjunction with Mirvaso

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 19, 2016
    Last Updated
    April 17, 2023
    Sponsor
    Skin Laser & Surgery Specialists
    Collaborators
    Galderma R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03508869
    Brief Title
    Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Terminated
    Why Stopped
    sponsor asked site to suspend study.
    Study Start Date
    September 27, 2016 (Actual)
    Primary Completion Date
    September 20, 2017 (Actual)
    Study Completion Date
    September 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Skin Laser & Surgery Specialists
    Collaborators
    Galderma R&D

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erythema and Flushing Associated With Rosacea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mirvaso® (brimonidine) topical gel, 0.33%
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Dysport®
    Arm Type
    Active Comparator
    Arm Description
    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
    Arm Title
    Dysport® in conjunction with Mirvaso
    Arm Type
    Active Comparator
    Arm Description
    Dysport® in conjunction with Mirvaso
    Intervention Type
    Drug
    Intervention Name(s)
    Mirvaso® (brimonidine) topical gel, 0.33%
    Intervention Description
    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
    Intervention Name(s)
    Dysport®
    Other Intervention Name(s)
    Dysport® (abobotulinumtoxinA)
    Intervention Description
    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
    Intervention Type
    Drug
    Intervention Name(s)
    Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
    Intervention Description
    Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
    Primary Outcome Measure Information:
    Title
    Efficacy Assessments for Erythema
    Description
    % 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
    Title
    Efficacy Assessments for Flushing
    Description
    % 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
    Secondary Outcome Measure Information:
    Title
    Safety Assessments
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female 18 years of age or older Clinical diagnosis of rosacea 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) No known medical conditions that may interfere with study participation Willingness to not use any products on their face for the duration of the study Read, understand, and sign informed consent forms Willingness to sign photography release form Willing and able to comply with all follow-up requirements Willingness to undergo treatment using Mirvaso® Gel and Dysport® Exclusion Criteria: Any significant skin disease at treatment area Any medical condition which could interfere with the treatment Inability or unwillingness to follow the treatment schedule Inability or unwillingness to sign the informed consent Pregnant or lactating Allergy to cow's milk protein Previous or current use of Mirvaso® Gel Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients Previous Dysport® treatment 6 months prior to the screening visit

    12. IPD Sharing Statement

    Learn more about this trial

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

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