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Trial record 82 of 152 for:    Brimonidine

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

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

Condition or disease Intervention/treatment Phase
Erythema and Flushing Associated With Rosacea Drug: Mirvaso® (brimonidine) topical gel, 0.33% Drug: Dysport® Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Rosacea

Arm Intervention/treatment
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.
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.

Active Comparator: Dysport®
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Drug: Dysport®
Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
Other Name: Dysport® (abobotulinumtoxinA)

Active Comparator: Dysport® in conjunction with Mirvaso
Dysport® in conjunction with Mirvaso
Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: David J. Goldberg, MD, Principal Investigator, Skin Laser & Surgery Specialists
ClinicalTrials.gov Identifier: NCT03508869     History of Changes
Other Study ID Numbers: MG-DYS-ROS
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Brimonidine Tartrate
Rosacea
Erythema
Flushing
Skin Diseases
Skin Manifestations
Signs and Symptoms
Adrenergic Agonists
Adrenergic alpha-Agonists
abobotulinumtoxinA
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Neuromuscular Blocking Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Membrane Transport Modulators
Cholinergic Agents
Neuromuscular Agents
Peripheral Nervous System Agents