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

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ClinicalTrials.gov Identifier: NCT03508869
Recruitment Status : Terminated (sponsor asked site to suspend study.)
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
David J. Goldberg, MD, Skin Laser & Surgery Specialists

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date April 26, 2018
Actual Study Start Date  ICMJE September 27, 2016
Actual Primary Completion Date September 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • Efficacy Assessments for Erythema [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Safety Assessments [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erythema and Flushing Associated With Rosacea
Intervention  ICMJE
  • Drug: 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.
  • Drug: Dysport®
    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
    Other Name: Dysport® (abobotulinumtoxinA)
  • Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
    Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Study Arms  ICMJE
  • Active Comparator: 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: Drug: Mirvaso® (brimonidine) topical gel, 0.33%
  • Active Comparator: Dysport®
    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
    Intervention: Drug: Dysport®
  • Active Comparator: Dysport® in conjunction with Mirvaso
    Dysport® in conjunction with Mirvaso
    Intervention: Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 16, 2018)
5
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2017
Actual Primary Completion Date September 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508869
Other Study ID Numbers  ICMJE MG-DYS-ROS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David J. Goldberg, MD, Skin Laser & Surgery Specialists
Study Sponsor  ICMJE Skin Laser & Surgery Specialists
Collaborators  ICMJE Galderma
Investigators  ICMJE Not Provided
PRS Account Skin Laser & Surgery Specialists
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP